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Registration: ISO 13485 / IEC 62304 Training
These training sessions will take place on Friday, 21-Oct-2016 at 640 Memorial Drive, Cambridge MA USA.
Morning topics covered will include:
Outline and of ISO 13485:2016, and differences from previous version
Basic quality expectations of ISO 13485
Impact of ISO 13485 on medical device software development
Afternoon topics will include:
Outline of IEC 62304 (medical device software lifecycle processes)
What IEC 62304 does and doesn't say
Relationship of both standards to the international risk management standard
Each session will include interactive discussions and opportunity for participants to raise their own questions.
Please use this form to register for one or both training session.
Job / Position Title
Please indicate your position (such as developer, architect, engineering manager, or database administrator)
Which session(s) do you plan to attend? (NOTE: Please tick a session even if you're unsure you'll attend.)
Morning: ISO 13485
Afternoon: IEC 62304
I'd like to know about each of the participants as we begin. What do you hope to learn in this training?
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