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

A

aryaakya

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.
 

yodon

Leader
Super Moderator
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.
 

Alice kazu

Registered
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.

Hello! I'm bringing up this old forum! :uhoh:

Did you find what you wanted? I'm looking for the same thing

ty! :bigwave:
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
can any one help with sample document for DOS for oil and gas service company

This is the medical device section of Elsmar.com. I suggest you post in the correct forum for a better response and to keep the forums aligned.
 
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