SlideShare una empresa de Scribd logo

2011 Webinar on Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs

•Descargar como DOCX, PDF•
•
S
supportc2go

The document summarizes a live webinar on medical device regulations in the EU. The webinar will discuss EU directives, guidance documents, the CE marking process, and ISO certification requirements for commercializing medical devices in Europe. Attendees will learn about classifying devices and the regulatory requirements for approval and marketing in the EU. The webinar leader has over 27 years of experience in medical device regulation in Europe and globally.

EmpresarialesSalud y medicina
1 de 4
[object Object]
2011 Webinar on Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs
2011 Webinar on Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs
2011 Webinar on Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs

Recomendados

Medical Devices: EU Directives, Guidance Documents, CE Marking Process and IS...
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and IS...Medical Devices: EU Directives, Guidance Documents, CE Marking Process and IS...
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and IS...ComplianceOnline
 
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...YourEncoreInc
 
CE marking and CE certification
CE marking and CE certificationCE marking and CE certification
CE marking and CE certificationmeddevicemarking
 
Malaysia Medical Devices Regulations
Malaysia Medical Devices RegulationsMalaysia Medical Devices Regulations
Malaysia Medical Devices RegulationsMourad Kholti
 
MDD 93/42/EEC
MDD 93/42/EECMDD 93/42/EEC
MDD 93/42/EECPavan Kumar Malwade
 
Addressing the challenge of the new European Union Medical Device Regulation
Addressing the challenge of the new European Union Medical Device RegulationAddressing the challenge of the new European Union Medical Device Regulation
Addressing the challenge of the new European Union Medical Device RegulationEY Belgium
 
EU Medical Devices Directive M5 Amendment 93 42 EEC Regulatory Update - BSI B...
EU Medical Devices Directive M5 Amendment 93 42 EEC Regulatory Update - BSI B...EU Medical Devices Directive M5 Amendment 93 42 EEC Regulatory Update - BSI B...
EU Medical Devices Directive M5 Amendment 93 42 EEC Regulatory Update - BSI B...BSI British Standards Institution
 
EU PV Modules - What are they?
EU PV Modules - What are they? EU PV Modules - What are they?
EU PV Modules - What are they? Vaska Toné
 

Recomendados

Medical Devices: EU Directives, Guidance Documents, CE Marking Process and IS...
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and IS...Medical Devices: EU Directives, Guidance Documents, CE Marking Process and IS...
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and IS...ComplianceOnline
 
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...
EU Medical Device Regulation: Preparing for Disruptive (yet Incomplete) Regu...YourEncoreInc
 
CE marking and CE certification
CE marking and CE certificationCE marking and CE certification
CE marking and CE certificationmeddevicemarking
 
Malaysia Medical Devices Regulations
Malaysia Medical Devices RegulationsMalaysia Medical Devices Regulations
Malaysia Medical Devices RegulationsMourad Kholti
 
MDD 93/42/EEC
MDD 93/42/EECMDD 93/42/EEC
MDD 93/42/EECPavan Kumar Malwade
 
Addressing the challenge of the new European Union Medical Device Regulation
Addressing the challenge of the new European Union Medical Device RegulationAddressing the challenge of the new European Union Medical Device Regulation
Addressing the challenge of the new European Union Medical Device RegulationEY Belgium
 
EU Medical Devices Directive M5 Amendment 93 42 EEC Regulatory Update - BSI B...
EU Medical Devices Directive M5 Amendment 93 42 EEC Regulatory Update - BSI B...EU Medical Devices Directive M5 Amendment 93 42 EEC Regulatory Update - BSI B...
EU Medical Devices Directive M5 Amendment 93 42 EEC Regulatory Update - BSI B...BSI British Standards Institution
 
EU PV Modules - What are they?
EU PV Modules - What are they? EU PV Modules - What are they?
EU PV Modules - What are they? Vaska Toné
 
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
 
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...Pallavi Christeen
 
Ce marking of medical devices
Ce marking of medical devicesCe marking of medical devices
Ce marking of medical devicesPallavi Christeen
 
Medical devices for_the_eu_070910
Medical devices for_the_eu_070910Medical devices for_the_eu_070910
Medical devices for_the_eu_070910Ondina Grigorescu
 
The ROI of Good Quality & Compliance
The ROI of Good Quality & ComplianceThe ROI of Good Quality & Compliance
The ROI of Good Quality & ComplianceMaetrics
 
Presentation: Manufacturing medical devices
Presentation: Manufacturing medical devicesPresentation: Manufacturing medical devices
Presentation: Manufacturing medical devicesTGA Australia
 
Changing medical device regulations in Europe and the U.S.
Changing medical device regulations in Europe and the U.S.Changing medical device regulations in Europe and the U.S.
Changing medical device regulations in Europe and the U.S.Maetrics
 
Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...
Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...
Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...Greenlight Guru
 
EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck
EU MDR Preparation: Seize the Market Opportunity and Avoid the BottleneckEU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck
EU MDR Preparation: Seize the Market Opportunity and Avoid the BottleneckApril Bright
 
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...NAMSA
 
How to Prepare for the New EU Medical Device Regulations (MDR)
How to Prepare for the New EU Medical Device Regulations (MDR)How to Prepare for the New EU Medical Device Regulations (MDR)
How to Prepare for the New EU Medical Device Regulations (MDR)Greenlight Guru
 
OSMA: Orthopedic Industry's Top Regulatory Challenges and Opportunities
OSMA: Orthopedic Industry's Top Regulatory Challenges and OpportunitiesOSMA: Orthopedic Industry's Top Regulatory Challenges and Opportunities
OSMA: Orthopedic Industry's Top Regulatory Challenges and OpportunitiesApril Bright
 
Presentation on marketing of medical devices in Europe (24.01.2012)
Presentation on marketing of medical devices in Europe (24.01.2012)Presentation on marketing of medical devices in Europe (24.01.2012)
Presentation on marketing of medical devices in Europe (24.01.2012)Christian Dekoninck
 
Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval
Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval
Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval Innovation Agency
 
Medical device management in china and latest regulatory updates_Edwin
Medical device management in china and latest regulatory updates_EdwinMedical device management in china and latest regulatory updates_Edwin
Medical device management in china and latest regulatory updates_EdwinCIRS China
 
Presentation: Life cycle of medical devices
Presentation: Life cycle of medical devicesPresentation: Life cycle of medical devices
Presentation: Life cycle of medical devicesTGA Australia
 
The ce marking process
The ce marking processThe ce marking process
The ce marking processLakshy Management Consultant Pvt Ltd
 
Eu hot topics alliance presentation
Eu hot topics alliance presentationEu hot topics alliance presentation
Eu hot topics alliance presentationErik Vollebregt
 
Eu hot topics alliance presentation 3
Eu hot topics alliance presentation 3Eu hot topics alliance presentation 3
Eu hot topics alliance presentation 3Erik Vollebregt
 
Medical device classification following MDR 2017/745
Medical device classification following MDR 2017/745Medical device classification following MDR 2017/745
Medical device classification following MDR 2017/745Monir EL AZZOUZI
 
Hi paa and eh rs
Hi paa and eh rsHi paa and eh rs
Hi paa and eh rssupportc2go
 
Hipaa audits and enforcement
Hipaa audits and enforcementHipaa audits and enforcement
Hipaa audits and enforcementsupportc2go
 

Más contenido relacionado

La actualidad más candente

Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
 
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...Pallavi Christeen
 
Ce marking of medical devices
Ce marking of medical devicesCe marking of medical devices
Ce marking of medical devicesPallavi Christeen
 
Medical devices for_the_eu_070910
Medical devices for_the_eu_070910Medical devices for_the_eu_070910
Medical devices for_the_eu_070910Ondina Grigorescu
 
The ROI of Good Quality & Compliance
The ROI of Good Quality & ComplianceThe ROI of Good Quality & Compliance
The ROI of Good Quality & ComplianceMaetrics
 
Presentation: Manufacturing medical devices
Presentation: Manufacturing medical devicesPresentation: Manufacturing medical devices
Presentation: Manufacturing medical devicesTGA Australia
 
Changing medical device regulations in Europe and the U.S.
Changing medical device regulations in Europe and the U.S.Changing medical device regulations in Europe and the U.S.
Changing medical device regulations in Europe and the U.S.Maetrics
 
Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...
Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...
Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...Greenlight Guru
 
EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck
EU MDR Preparation: Seize the Market Opportunity and Avoid the BottleneckEU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck
EU MDR Preparation: Seize the Market Opportunity and Avoid the BottleneckApril Bright
 
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...NAMSA
 
How to Prepare for the New EU Medical Device Regulations (MDR)
How to Prepare for the New EU Medical Device Regulations (MDR)How to Prepare for the New EU Medical Device Regulations (MDR)
How to Prepare for the New EU Medical Device Regulations (MDR)Greenlight Guru
 
OSMA: Orthopedic Industry's Top Regulatory Challenges and Opportunities
OSMA: Orthopedic Industry's Top Regulatory Challenges and OpportunitiesOSMA: Orthopedic Industry's Top Regulatory Challenges and Opportunities
OSMA: Orthopedic Industry's Top Regulatory Challenges and OpportunitiesApril Bright
 
Presentation on marketing of medical devices in Europe (24.01.2012)
Presentation on marketing of medical devices in Europe (24.01.2012)Presentation on marketing of medical devices in Europe (24.01.2012)
Presentation on marketing of medical devices in Europe (24.01.2012)Christian Dekoninck
 
Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval
Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval
Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval Innovation Agency
 
Medical device management in china and latest regulatory updates_Edwin
Medical device management in china and latest regulatory updates_EdwinMedical device management in china and latest regulatory updates_Edwin
Medical device management in china and latest regulatory updates_EdwinCIRS China
 
Presentation: Life cycle of medical devices
Presentation: Life cycle of medical devicesPresentation: Life cycle of medical devices
Presentation: Life cycle of medical devicesTGA Australia
 
Eu hot topics alliance presentation
Eu hot topics alliance presentationEu hot topics alliance presentation
Eu hot topics alliance presentationErik Vollebregt
 
Eu hot topics alliance presentation 3
Eu hot topics alliance presentation 3Eu hot topics alliance presentation 3
Eu hot topics alliance presentation 3Erik Vollebregt
 
Medical device classification following MDR 2017/745
Medical device classification following MDR 2017/745Medical device classification following MDR 2017/745
Medical device classification following MDR 2017/745Monir EL AZZOUZI
 

La actualidad más candente (20)

Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...
 
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...
 
Ce marking of medical devices
Ce marking of medical devicesCe marking of medical devices
Ce marking of medical devices
 
Medical devices for_the_eu_070910
Medical devices for_the_eu_070910Medical devices for_the_eu_070910
Medical devices for_the_eu_070910
 
The ROI of Good Quality & Compliance
The ROI of Good Quality & ComplianceThe ROI of Good Quality & Compliance
The ROI of Good Quality & Compliance
 
Presentation: Manufacturing medical devices
Presentation: Manufacturing medical devicesPresentation: Manufacturing medical devices
Presentation: Manufacturing medical devices
 
Changing medical device regulations in Europe and the U.S.
Changing medical device regulations in Europe and the U.S.Changing medical device regulations in Europe and the U.S.
Changing medical device regulations in Europe and the U.S.
 
Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...
Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...
Clinical Evaluation in the EU for Medical Devices: Understanding the Changes ...
 
EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck
EU MDR Preparation: Seize the Market Opportunity and Avoid the BottleneckEU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck
EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck
 
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...
Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medi...
 
How to Prepare for the New EU Medical Device Regulations (MDR)
How to Prepare for the New EU Medical Device Regulations (MDR)How to Prepare for the New EU Medical Device Regulations (MDR)
How to Prepare for the New EU Medical Device Regulations (MDR)
 
OSMA: Orthopedic Industry's Top Regulatory Challenges and Opportunities
OSMA: Orthopedic Industry's Top Regulatory Challenges and OpportunitiesOSMA: Orthopedic Industry's Top Regulatory Challenges and Opportunities
OSMA: Orthopedic Industry's Top Regulatory Challenges and Opportunities
 
Presentation on marketing of medical devices in Europe (24.01.2012)
Presentation on marketing of medical devices in Europe (24.01.2012)Presentation on marketing of medical devices in Europe (24.01.2012)
Presentation on marketing of medical devices in Europe (24.01.2012)
 
Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval
Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval
Ed Ball - Liverpool City Region SME workshop: Regulatory process and approval
 
Medical device management in china and latest regulatory updates_Edwin
Medical device management in china and latest regulatory updates_EdwinMedical device management in china and latest regulatory updates_Edwin
Medical device management in china and latest regulatory updates_Edwin
 
Presentation: Life cycle of medical devices
Presentation: Life cycle of medical devicesPresentation: Life cycle of medical devices
Presentation: Life cycle of medical devices
 
The ce marking process
The ce marking processThe ce marking process
The ce marking process
 
Eu hot topics alliance presentation
Eu hot topics alliance presentationEu hot topics alliance presentation
Eu hot topics alliance presentation
 
Eu hot topics alliance presentation 3
Eu hot topics alliance presentation 3Eu hot topics alliance presentation 3
Eu hot topics alliance presentation 3
 
Medical device classification following MDR 2017/745
Medical device classification following MDR 2017/745Medical device classification following MDR 2017/745
Medical device classification following MDR 2017/745
 

Destacado

Hi paa and eh rs
Hi paa and eh rsHi paa and eh rs
Hi paa and eh rssupportc2go
 
Hipaa audits and enforcement
Hipaa audits and enforcementHipaa audits and enforcement
Hipaa audits and enforcementsupportc2go
 
Preparing for fda
Preparing for fdaPreparing for fda
Preparing for fdasupportc2go
 
Hipaa random audit
Hipaa random auditHipaa random audit
Hipaa random auditsupportc2go
 

Destacado (6)

Hi paa and eh rs
Hi paa and eh rsHi paa and eh rs
Hi paa and eh rs
 
Hipaa audits and enforcement
Hipaa audits and enforcementHipaa audits and enforcement
Hipaa audits and enforcement
 
Preparing for fda
Preparing for fdaPreparing for fda
Preparing for fda
 
Dmf
DmfDmf
Dmf
 
Eu
EuEu
Eu
 
Hipaa random audit
Hipaa random auditHipaa random audit
Hipaa random audit
 

Similar a 2011 Webinar on Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs

presentation-ema-experience-mdr-implementation_en.pdf
presentation-ema-experience-mdr-implementation_en.pdfpresentation-ema-experience-mdr-implementation_en.pdf
presentation-ema-experience-mdr-implementation_en.pdfBalaji Kuzhandhaivelu
 
PECB Webinar: Proposed changes for medical device quality management systems ...
PECB Webinar: Proposed changes for medical device quality management systems ...PECB Webinar: Proposed changes for medical device quality management systems ...
PECB Webinar: Proposed changes for medical device quality management systems ...PECB
 
Tuv sud-ivdr-infosheet - EU’s In Vitro Diagnostic Medical Device Regulation
Tuv sud-ivdr-infosheet - EU’s In Vitro Diagnostic Medical Device RegulationTuv sud-ivdr-infosheet - EU’s In Vitro Diagnostic Medical Device Regulation
Tuv sud-ivdr-infosheet - EU’s In Vitro Diagnostic Medical Device RegulationStefano Bolletta
 
The EU’s Medical Device Regulation
The EU’s Medical Device RegulationThe EU’s Medical Device Regulation
The EU’s Medical Device RegulationStefano Bolletta
 
Potential effects of the upcoming Regulations By Dr. J O’ Dwyer -NSAI (Qserve...
Potential effects of the upcoming Regulations By Dr. J O’ Dwyer -NSAI (Qserve...Potential effects of the upcoming Regulations By Dr. J O’ Dwyer -NSAI (Qserve...
Potential effects of the upcoming Regulations By Dr. J O’ Dwyer -NSAI (Qserve...qserveconference2013
 
Medical Device Regulatory Affairs.
Medical Device Regulatory Affairs.Medical Device Regulatory Affairs.
Medical Device Regulatory Affairs.Anjali Gupta
 
Rigel Medical-The-Pulse-Issue-4
Rigel Medical-The-Pulse-Issue-4Rigel Medical-The-Pulse-Issue-4
Rigel Medical-The-Pulse-Issue-4Medical IT
 
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...ulmedical
 
How to Prepare for the New EU In Vitro Diagnostics Regulations
How to Prepare for the New EU In Vitro Diagnostics RegulationsHow to Prepare for the New EU In Vitro Diagnostics Regulations
How to Prepare for the New EU In Vitro Diagnostics RegulationsGreenlight Guru
 
Quality regulation for biological products current and future
Quality regulation for biological products current and futureQuality regulation for biological products current and future
Quality regulation for biological products current and futureNational Institute of Biologics
 
Reg summary
Reg summaryReg summary
Reg summaryruyang89
 
2. 신규 체외진단법 도입에 따른 의료기기산업에 미치는 영향.pptx
2. 신규 체외진단법 도입에 따른 의료기기산업에 미치는 영향.pptx2. 신규 체외진단법 도입에 따른 의료기기산업에 미치는 영향.pptx
2. 신규 체외진단법 도입에 따른 의료기기산업에 미치는 영향.pptxDrSivakumarSelvaraj
 
The New EU MDR and What You Need to Know
The New EU MDR and What You Need to KnowThe New EU MDR and What You Need to Know
The New EU MDR and What You Need to KnowEMMAIntl
 
cmc [ chemistry manufacturing control ]
cmc [ chemistry manufacturing control ]cmc [ chemistry manufacturing control ]
cmc [ chemistry manufacturing control ]Akshay Patil
 
clinical-evaluation-report (CER)
clinical-evaluation-report (CER)clinical-evaluation-report (CER)
clinical-evaluation-report (CER)PEPGRA Healthcare
 

Similar a 2011 Webinar on Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs (20)

presentation-ema-experience-mdr-implementation_en.pdf
presentation-ema-experience-mdr-implementation_en.pdfpresentation-ema-experience-mdr-implementation_en.pdf
presentation-ema-experience-mdr-implementation_en.pdf
 
PECB Webinar: Proposed changes for medical device quality management systems ...
PECB Webinar: Proposed changes for medical device quality management systems ...PECB Webinar: Proposed changes for medical device quality management systems ...
PECB Webinar: Proposed changes for medical device quality management systems ...
 
ISO 13485 Certification.pdf
ISO 13485 Certification.pdfISO 13485 Certification.pdf
ISO 13485 Certification.pdf
 
ISO 13485 Medical Manufature.pdf
ISO 13485 Medical Manufature.pdfISO 13485 Medical Manufature.pdf
ISO 13485 Medical Manufature.pdf
 
Tuv sud-ivdr-infosheet - EU’s In Vitro Diagnostic Medical Device Regulation
Tuv sud-ivdr-infosheet - EU’s In Vitro Diagnostic Medical Device RegulationTuv sud-ivdr-infosheet - EU’s In Vitro Diagnostic Medical Device Regulation
Tuv sud-ivdr-infosheet - EU’s In Vitro Diagnostic Medical Device Regulation
 
The EU’s Medical Device Regulation
The EU’s Medical Device RegulationThe EU’s Medical Device Regulation
The EU’s Medical Device Regulation
 
Potential effects of the upcoming Regulations By Dr. J O’ Dwyer -NSAI (Qserve...
Potential effects of the upcoming Regulations By Dr. J O’ Dwyer -NSAI (Qserve...Potential effects of the upcoming Regulations By Dr. J O’ Dwyer -NSAI (Qserve...
Potential effects of the upcoming Regulations By Dr. J O’ Dwyer -NSAI (Qserve...
 
Medical Device Regulatory Affairs.
Medical Device Regulatory Affairs.Medical Device Regulatory Affairs.
Medical Device Regulatory Affairs.
 
Rigel Medical-The-Pulse-Issue-4
Rigel Medical-The-Pulse-Issue-4Rigel Medical-The-Pulse-Issue-4
Rigel Medical-The-Pulse-Issue-4
 
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...
 
How to Prepare for the New EU In Vitro Diagnostics Regulations
How to Prepare for the New EU In Vitro Diagnostics RegulationsHow to Prepare for the New EU In Vitro Diagnostics Regulations
How to Prepare for the New EU In Vitro Diagnostics Regulations
 
Quality regulation for biological products current and future
Quality regulation for biological products current and futureQuality regulation for biological products current and future
Quality regulation for biological products current and future
 
Reg summary
Reg summaryReg summary
Reg summary
 
Unique device identification
Unique device identificationUnique device identification
Unique device identification
 
Advamed MDR IVDR update
Advamed MDR IVDR updateAdvamed MDR IVDR update
Advamed MDR IVDR update
 
2. 신규 체외진단법 도입에 따른 의료기기산업에 미치는 영향.pptx
2. 신규 체외진단법 도입에 따른 의료기기산업에 미치는 영향.pptx2. 신규 체외진단법 도입에 따른 의료기기산업에 미치는 영향.pptx
2. 신규 체외진단법 도입에 따른 의료기기산업에 미치는 영향.pptx
 
The New EU MDR and What You Need to Know
The New EU MDR and What You Need to KnowThe New EU MDR and What You Need to Know
The New EU MDR and What You Need to Know
 
cmc [ chemistry manufacturing control ]
cmc [ chemistry manufacturing control ]cmc [ chemistry manufacturing control ]
cmc [ chemistry manufacturing control ]
 
clinical-evaluation-report (CER)
clinical-evaluation-report (CER)clinical-evaluation-report (CER)
clinical-evaluation-report (CER)
 
Med Byte
Med ByteMed Byte
Med Byte
 

Más de supportc2go

Understanding design
Understanding designUnderstanding design
Understanding designsupportc2go
 
Hipaa audits and enforcement
Hipaa audits and enforcementHipaa audits and enforcement
Hipaa audits and enforcementsupportc2go
 
Hi paa and eh rs
Hi paa and eh rsHi paa and eh rs
Hi paa and eh rssupportc2go
 
Excel spreadsheet
Excel spreadsheetExcel spreadsheet
Excel spreadsheetsupportc2go
 
Design history file
Design history fileDesign history file
Design history filesupportc2go
 
Excel spreadsheet
Excel spreadsheetExcel spreadsheet
Excel spreadsheetsupportc2go
 
Live webinar on sop
Live webinar on sopLive webinar on sop
Live webinar on sopsupportc2go
 
Live webinar on lypolization
Live webinar on lypolizationLive webinar on lypolization
Live webinar on lypolizationsupportc2go
 
Live Webinar on Lyophilization Process Development and Cycle Design
Live Webinar on Lyophilization Process Development and Cycle DesignLive Webinar on Lyophilization Process Development and Cycle Design
Live Webinar on Lyophilization Process Development and Cycle Designsupportc2go
 

Más de supportc2go (16)

Understanding design
Understanding designUnderstanding design
Understanding design
 
Risk analysis
Risk analysisRisk analysis
Risk analysis
 
Hipaa audits and enforcement
Hipaa audits and enforcementHipaa audits and enforcement
Hipaa audits and enforcement
 
Hi paa and eh rs
Hi paa and eh rsHi paa and eh rs
Hi paa and eh rs
 
Excel spreadsheet
Excel spreadsheetExcel spreadsheet
Excel spreadsheet
 
Design history file
Design history fileDesign history file
Design history file
 
Cots software
Cots softwareCots software
Cots software
 
Excel spreadsheet
Excel spreadsheetExcel spreadsheet
Excel spreadsheet
 
Live webinar on sop
Live webinar on sopLive webinar on sop
Live webinar on sop
 
Gmp 1
Gmp 1Gmp 1
Gmp 1
 
Dmf
DmfDmf
Dmf
 
Capa
CapaCapa
Capa
 
Post market
Post marketPost market
Post market
 
21 cfr part 11
21 cfr part 1121 cfr part 11
21 cfr part 11
 
Live webinar on lypolization
Live webinar on lypolizationLive webinar on lypolization
Live webinar on lypolization
 
Live Webinar on Lyophilization Process Development and Cycle Design
Live Webinar on Lyophilization Process Development and Cycle DesignLive Webinar on Lyophilization Process Development and Cycle Design
Live Webinar on Lyophilization Process Development and Cycle Design
 

Último

Driving Business Impact for PMs with Jon Harmer
Driving Business Impact for PMs with Jon HarmerDriving Business Impact for PMs with Jon Harmer
Driving Business Impact for PMs with Jon HarmerAggregage
 
Memorándum de Entendimiento (MoU) entre Codelco y SQM
Memorándum de Entendimiento (MoU) entre Codelco y SQMMemorándum de Entendimiento (MoU) entre Codelco y SQM
Memorándum de Entendimiento (MoU) entre Codelco y SQMVoces Mineras
 
Unveiling the Soundscape Music for Psychedelic Experiences
Unveiling the Soundscape Music for Psychedelic ExperiencesUnveiling the Soundscape Music for Psychedelic Experiences
Unveiling the Soundscape Music for Psychedelic ExperiencesDoe Paoro
 
Welding Electrode Making Machine By Deccan Dynamics
Welding Electrode Making Machine By Deccan DynamicsWelding Electrode Making Machine By Deccan Dynamics
Welding Electrode Making Machine By Deccan DynamicsIndiaMART InterMESH Limited
 
Technical Leaders - Working with the Management Team
Technical Leaders - Working with the Management TeamTechnical Leaders - Working with the Management Team
Technical Leaders - Working with the Management TeamArik Fletcher
 
Appkodes Tinder Clone Script with Customisable Solutions.pptx
Appkodes Tinder Clone Script with Customisable Solutions.pptxAppkodes Tinder Clone Script with Customisable Solutions.pptx
Appkodes Tinder Clone Script with Customisable Solutions.pptxappkodes
 
20220816-EthicsGrade_Scorecard-JP_Morgan_Chase-Q2-63_57.pdf
20220816-EthicsGrade_Scorecard-JP_Morgan_Chase-Q2-63_57.pdf20220816-EthicsGrade_Scorecard-JP_Morgan_Chase-Q2-63_57.pdf
20220816-EthicsGrade_Scorecard-JP_Morgan_Chase-Q2-63_57.pdfChris Skinner
 
WSMM Technology February.March Newsletter_vF.pdf
WSMM Technology February.March Newsletter_vF.pdfWSMM Technology February.March Newsletter_vF.pdf
WSMM Technology February.March Newsletter_vF.pdfJamesConcepcion7
 
Go for Rakhi Bazaar and Pick the Latest Bhaiya Bhabhi Rakhi.pptx
Go for Rakhi Bazaar and Pick the Latest Bhaiya Bhabhi Rakhi.pptxGo for Rakhi Bazaar and Pick the Latest Bhaiya Bhabhi Rakhi.pptx
Go for Rakhi Bazaar and Pick the Latest Bhaiya Bhabhi Rakhi.pptxRakhi Bazaar
 
APRIL2024_UKRAINE_xml_0000000000000 .pdf
APRIL2024_UKRAINE_xml_0000000000000 .pdfAPRIL2024_UKRAINE_xml_0000000000000 .pdf
APRIL2024_UKRAINE_xml_0000000000000 .pdfRbc Rbcua
 
Jewish Resources in the Family Resource Centre
Jewish Resources in the Family Resource CentreJewish Resources in the Family Resource Centre
Jewish Resources in the Family Resource CentreNZSG
 
Lucia Ferretti, Lead Business Designer; Matteo Meschini, Business Designer @T...
Lucia Ferretti, Lead Business Designer; Matteo Meschini, Business Designer @T...Lucia Ferretti, Lead Business Designer; Matteo Meschini, Business Designer @T...
Lucia Ferretti, Lead Business Designer; Matteo Meschini, Business Designer @T...Associazione Digital Days
 
Intermediate Accounting, Volume 2, 13th Canadian Edition by Donald E. Kieso t...
Intermediate Accounting, Volume 2, 13th Canadian Edition by Donald E. Kieso t...Intermediate Accounting, Volume 2, 13th Canadian Edition by Donald E. Kieso t...
Intermediate Accounting, Volume 2, 13th Canadian Edition by Donald E. Kieso t...ssuserf63bd7
 
Onemonitar Android Spy App Features: Explore Advanced Monitoring Capabilities
Onemonitar Android Spy App Features: Explore Advanced Monitoring CapabilitiesOnemonitar Android Spy App Features: Explore Advanced Monitoring Capabilities
Onemonitar Android Spy App Features: Explore Advanced Monitoring CapabilitiesOne Monitar
 
The-Ethical-issues-ghhhhhhhhjof-Byjus.pptx
The-Ethical-issues-ghhhhhhhhjof-Byjus.pptxThe-Ethical-issues-ghhhhhhhhjof-Byjus.pptx
The-Ethical-issues-ghhhhhhhhjof-Byjus.pptxmbikashkanyari
 
Horngren’s Financial & Managerial Accounting, 7th edition by Miller-Nobles so...
Horngren’s Financial & Managerial Accounting, 7th edition by Miller-Nobles so...Horngren’s Financial & Managerial Accounting, 7th edition by Miller-Nobles so...
Horngren’s Financial & Managerial Accounting, 7th edition by Miller-Nobles so...ssuserf63bd7
 
PSCC - Capability Statement Presentation
PSCC - Capability Statement PresentationPSCC - Capability Statement Presentation
PSCC - Capability Statement PresentationAnamaria Contreras
 
WSMM Media and Entertainment Feb_March_Final.pdf
WSMM Media and Entertainment Feb_March_Final.pdfWSMM Media and Entertainment Feb_March_Final.pdf
WSMM Media and Entertainment Feb_March_Final.pdfJamesConcepcion7
 

Último (20)

Driving Business Impact for PMs with Jon Harmer
Driving Business Impact for PMs with Jon HarmerDriving Business Impact for PMs with Jon Harmer
Driving Business Impact for PMs with Jon Harmer
 
Memorándum de Entendimiento (MoU) entre Codelco y SQM
Memorándum de Entendimiento (MoU) entre Codelco y SQMMemorándum de Entendimiento (MoU) entre Codelco y SQM
Memorándum de Entendimiento (MoU) entre Codelco y SQM
 
Unveiling the Soundscape Music for Psychedelic Experiences
Unveiling the Soundscape Music for Psychedelic ExperiencesUnveiling the Soundscape Music for Psychedelic Experiences
Unveiling the Soundscape Music for Psychedelic Experiences
 
Welding Electrode Making Machine By Deccan Dynamics
Welding Electrode Making Machine By Deccan DynamicsWelding Electrode Making Machine By Deccan Dynamics
Welding Electrode Making Machine By Deccan Dynamics
 
WAM Corporate Presentation April 12 2024.pdf
WAM Corporate Presentation April 12 2024.pdfWAM Corporate Presentation April 12 2024.pdf
WAM Corporate Presentation April 12 2024.pdf
 
Technical Leaders - Working with the Management Team
Technical Leaders - Working with the Management TeamTechnical Leaders - Working with the Management Team
Technical Leaders - Working with the Management Team
 
Appkodes Tinder Clone Script with Customisable Solutions.pptx
Appkodes Tinder Clone Script with Customisable Solutions.pptxAppkodes Tinder Clone Script with Customisable Solutions.pptx
Appkodes Tinder Clone Script with Customisable Solutions.pptx
 
20220816-EthicsGrade_Scorecard-JP_Morgan_Chase-Q2-63_57.pdf
20220816-EthicsGrade_Scorecard-JP_Morgan_Chase-Q2-63_57.pdf20220816-EthicsGrade_Scorecard-JP_Morgan_Chase-Q2-63_57.pdf
20220816-EthicsGrade_Scorecard-JP_Morgan_Chase-Q2-63_57.pdf
 
WSMM Technology February.March Newsletter_vF.pdf
WSMM Technology February.March Newsletter_vF.pdfWSMM Technology February.March Newsletter_vF.pdf
WSMM Technology February.March Newsletter_vF.pdf
 
Go for Rakhi Bazaar and Pick the Latest Bhaiya Bhabhi Rakhi.pptx
Go for Rakhi Bazaar and Pick the Latest Bhaiya Bhabhi Rakhi.pptxGo for Rakhi Bazaar and Pick the Latest Bhaiya Bhabhi Rakhi.pptx
Go for Rakhi Bazaar and Pick the Latest Bhaiya Bhabhi Rakhi.pptx
 
APRIL2024_UKRAINE_xml_0000000000000 .pdf
APRIL2024_UKRAINE_xml_0000000000000 .pdfAPRIL2024_UKRAINE_xml_0000000000000 .pdf
APRIL2024_UKRAINE_xml_0000000000000 .pdf
 
Jewish Resources in the Family Resource Centre
Jewish Resources in the Family Resource CentreJewish Resources in the Family Resource Centre
Jewish Resources in the Family Resource Centre
 
Lucia Ferretti, Lead Business Designer; Matteo Meschini, Business Designer @T...
Lucia Ferretti, Lead Business Designer; Matteo Meschini, Business Designer @T...Lucia Ferretti, Lead Business Designer; Matteo Meschini, Business Designer @T...
Lucia Ferretti, Lead Business Designer; Matteo Meschini, Business Designer @T...
 
Intermediate Accounting, Volume 2, 13th Canadian Edition by Donald E. Kieso t...
Intermediate Accounting, Volume 2, 13th Canadian Edition by Donald E. Kieso t...Intermediate Accounting, Volume 2, 13th Canadian Edition by Donald E. Kieso t...
Intermediate Accounting, Volume 2, 13th Canadian Edition by Donald E. Kieso t...
 
Onemonitar Android Spy App Features: Explore Advanced Monitoring Capabilities
Onemonitar Android Spy App Features: Explore Advanced Monitoring CapabilitiesOnemonitar Android Spy App Features: Explore Advanced Monitoring Capabilities
Onemonitar Android Spy App Features: Explore Advanced Monitoring Capabilities
 
The-Ethical-issues-ghhhhhhhhjof-Byjus.pptx
The-Ethical-issues-ghhhhhhhhjof-Byjus.pptxThe-Ethical-issues-ghhhhhhhhjof-Byjus.pptx
The-Ethical-issues-ghhhhhhhhjof-Byjus.pptx
 
Horngren’s Financial & Managerial Accounting, 7th edition by Miller-Nobles so...
Horngren’s Financial & Managerial Accounting, 7th edition by Miller-Nobles so...Horngren’s Financial & Managerial Accounting, 7th edition by Miller-Nobles so...
Horngren’s Financial & Managerial Accounting, 7th edition by Miller-Nobles so...
 
PSCC - Capability Statement Presentation
PSCC - Capability Statement PresentationPSCC - Capability Statement Presentation
PSCC - Capability Statement Presentation
 
The Bizz Quiz-E-Summit-E-Cell-IITPatna.pptx
The Bizz Quiz-E-Summit-E-Cell-IITPatna.pptxThe Bizz Quiz-E-Summit-E-Cell-IITPatna.pptx
The Bizz Quiz-E-Summit-E-Cell-IITPatna.pptx
 
WSMM Media and Entertainment Feb_March_Final.pdf
WSMM Media and Entertainment Feb_March_Final.pdfWSMM Media and Entertainment Feb_March_Final.pdf
WSMM Media and Entertainment Feb_March_Final.pdf
 

2011 Webinar on Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs

  • 1.