The document discusses medical device regulations from various agencies like the FDA and EU, which classify devices based on risk into Classes I to III. It also covers quality management systems like ISO 13485 that are important for product development and design controls. The key elements of design control as required by regulatory agencies are also summarized, including design planning, input, output, review, verification, and validation.

1. Medtech
regs 101
Generator
THE
powered by

2. Every medicaldevice is
regulated in some wayby
regulatory agencies
FDA
TGA
European Commission
Health Canada
Etc.

3. The rules are different (but
similar)for each regulatory
agency…

4. Lets start with
product classification

5. FDA

6. http://www.emergogroup.com/resources/videos-us-fda-
regulatory-process

7. FDA
Class I
Class II
Class III
Low Risk
High Risk

8. Intended Use
is the general purpose of the medical device or its
function (what you “claim” the medical device does)
Indications for Use
describe the disease or condition the medical device
will diagnose, treat, prevent, cure, or mitigate,
including a description of the target patient
population

9. Have a Go…
what is yourintended use and
indications foruse?

10. Without boring you with too many details, FDA has established
several general categories based on the medical specialty: CFR
21 Parts 862 to 892.
The details provided give me some idea if my intended use and
indications for use align with this specific regulation.
You also discover the FDA device classification
Findthe regulation

11. Go to the FDA Product Classification Database and type in the
regulations number you found. If you find more than one
possibility, then you will need to repeat this process for each.
You can then review each individual code to determine the best
option for your product by clicking on each code.
Findthe product codes

12. Here are the options:
Class I (low to moderate risk): general controls
Class II (moderate to high risk): general controls and Special
Controls
Class III (high risk): general controls and Premarket Approval
(PMA)
Determine FDA path to market

13. EU

14. Determine if your medical device is:
•Non-Invasive
•Invasive
•Active
Determine the EU classification per Annex IX in
the Medical Device Directive (93/42/EEC as
modified by 2007/47/EC)
• Class I
• Class IIa
• Class IIb
• Class III

15. And Software?

16. Software intended by the manufacturer to be
used for one or more medical purposes (as
defined as a medical device), is a medical device.
Standalone software for general purposes when
used in a healthcare setting is not a medical
device.
Software as adevice?

17. Class A: No injury or damage to health is possible
Class B: Non-SERIOUS INJURY is possible
Class C: Death or SERIOUS INJURY is possible
IEC 62304

18. This is only your
STARTINGpoint

19. Product development
and design controls

20. QualityManagement Systems
ISO 13485
- Medical Devices – Quality
management systems –
Requirements for regulatory
purposes
ISO 9001
- Quality Management Systems –
Requirements
GMP
- Good Manufacturing Practices -
ISO 14971
- Risk Management for Medical
Devices -

21. Whatisa qualitysystem?
Simplified, it means a set way of
doing all the tasks involved in the
development and manufacture of
the device/item

22. Some of the processes controlled by ISO guidelines and make up a
quality system:
Purchasing
Inwards
goods check Manufacture
Release for
sale
Equipment
maintenance
Personnel training
Distribution,
warehouse
Customer
receives
goods
Customer
satisfaction
Approval of
suppliers
Qualitysystems

23. If a companies systems are satisfactory, they are ‘ISO
certified’.
• They are awarded with an ISO certificate (internationally recognised)
Can outsource the development and manufacture of a
medical device to a company that has ISO 13485 certification

24. • Design and Development Planning
• Design Input
• Design Output
• Design Review
• Design Verification
• Design Validation
• Design Transfer
• Design Changes
• The Design History File
Key elementsof design control

25. Design Control mandates a formal, defined "Start Date."
Design control“start”date
Describe or reference design & development activities and
define responsibility for implementation
Design & Developmentplanning

26. Address the intended use of the device, including the needs of
the user/clinician and patient, the use environment, as well as
meeting the requirements of any applicable standards
mandated in the market(s) in which theproduct will be sold
Design Input
Allows evaluation of conformance to design input requirements
(acceptance criteria, identifies design outputs that are essential
for the proper functioning of the device)
Design OUTPUT

27. Formal reviews of the design results at planned stages of the
device’s development
Design REVIEWS
Verifying, testing and/or inspecting the device design to
confirm that the design output meets the design input
requirements
Design Verification

28. Performed under defined operating conditions on initial
production units, lots, batches or equivalents
Design VALIDATION
The manufacturer ensures that the device design is correctly
translated into production specifications – this ensures that
manufactured devices are repeatedly and reliably produced
within product and process capabilities
Design TRANSFER

29. All changes must be identified, documented, reviewed and
approved before being implemented. There are two principal
administrative elements/activities involved in the controlling of
design changes:
1. Document Control
2. Change Control
Design CHANGES

30. Clear as muD?

31. WANT TO KNOWMORE?
GET IN TOUCH!
www.monash.edu/entrepreneurship
@monashGENERATOR
Facebook.com/monashGENERATOR
7 Innovation Walk AG01-04 (Clayton Campus)
entrepreneurship@monash.edu