Sample document on design and development activities plan for a medical device

A

aryaakya

#1
Dear members,
Could you please any body give me a sample document on design and development plan for a medical device.
I need to prepare for that one,i am in little confuse on this topic,please help me out.

Waiting for your reply.
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Hi aryaaka, welcome to the cove.

First off, have you checked the post attachments archives? There's a link to take you to that search page.

Second, just handing over docs or templates is a bit risky since it may not reflect your business practice, your software (safety) classification, etc. It's typically more effective (and you typically get better responses) if you can post specific questions.

As far as a planning goes for software, you typically want to address what you will do (to what level of design documentation [if any] will be created, will you do unit and/or integration level testing and if so to what extent, etc.). A good guide is IEC 62304. You will also want to consider (possibly in separate plan(s)) aspects of configuration and release management, risk management, and verification and validation.

Again, if you can provide specific issues you're struggling with, we may be able to offer more helpful information.
 
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