Product safety, reliability, and compliance with relevant standards and regulations are the most important concerns for developers of medical devices. In the meantime, companies operating in the medical device industry are facing increasing market pressure to develop high quality products as fast as possible. Therefore, a huge competitive advantage is to be gained from mastering process control and automation in software development to allow the implementation of Agile while maintaining compliance with standards such as IEC 62304, ISO 14971, IEC 60601, and various FDA regulations. Check out our webinar to learn how Agile can be implemented and used reliably in such a highly regulated sector. We discuss adequate development and risk management processes; documenting all your development activities; and demonstrating end-to-end traceability throughout the lifecycle. At the end of the webinar, we showcase codeBeamer's relevant features and its preconfigured medical template during a live demonstration.

1. Agile + IEC 62304: Implementing Agile in
Medical Device Development
Peter Haller
23 March 2016

2. 2
Agenda
1. Introduction of Intland Software
2. Medical device development, challenges
3. Regulatory compliance
4. Adopting Agile in medical device development
5. Continuous compliance
6. Live demo

3. 3
Transitioning to Agile in Safety-Critical Device Development
Webinar info
o Live demonstration will be followed by a Q&A
session
o Webinar recording will be available at
www.intland.com/webinars/
o Sign up for our upcoming webinars

4. 4
o Founded in 1998
o Headquarters in Stuttgart, Germany
o Office in Silicon Valley, CA, USA
o Partners Lufthansa Industry Solutions, and resellers
in Korea & Taiwan
o codeBeamer ALM components:
• Requirements Management
• Software Development Management
• QA & Test Management
• Demand Management
• IT Operations (DevOps)
Introduction
Intland Software

5. 5
Intland Software
Medical
Automotive
Aviation &
Defence
High Tech &
Embedded
Other
Customers

6. 6
o Industry standards influencing the
manufacturing of medical devices:
o IEC 62304 – Medical device
software lifecycle processes
o ISO 14971 – Application of risk
management to medical
devices
o FDA regulations
Agile + IEC 62304: Implementing Agile in Medical Device Development
Industry regulations and standards

7. 7
Agile + IEC 62304: Implementing Agile in Medical Device Development
Medical device recalls in recent years

8. 8
• What is Agile?
“Agile is a time boxed, iterative approach to software delivery that builds software
incrementally from the start of the project, instead of trying to deliver it all at once
near the end.” (agilenuteshell.com)
Agile + IEC 62304: Implementing Agile in Medical Device Development
Agile in a nutshell – The Agile Manifesto
Individuals and interactions over Processes and tools
Customer collaboration over Contract negotiation
Working software over Comprehensive documentation
Responding to change over Following a plan
“That is, while there is value in the items on the right, we
value the items on the left more” (Agile Manifesto)

9. 9
Agile + IEC 62304: Implementing Agile in Medical Device Development
Adopting Agile and Continuous compliance
• Process control
• Automation
• Documentation
• Reduce risks
• Reduce the time to market
• Increased efficiency and product quality
• Gapless traceability

10. 10
codeBeamer Live Demo

11. Thank you for your attention!
Any questions?
sales@intland.com