Content to be included or excluded in Design Control Meeting Minutes

I

iso-13485

#1
We are an early stage medical device company that will be aiming for 13485 certification soon. We have implemented a paper based quality system and are in the Concept/Feasibility stage of Design Control.

Are there any guidelines for type of content to be included or excluded, i.e. facts, opinions etc.?

-Specifically pertaining to meeting with physicians who provide input to design concepts, comment on user needs, and potential risks and hazards.

-Also for meetings with engineers discussing design concepts

What should we include/exclude in terms of content?

Thanks!
 
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Marcelo

Inactive Registered Visitor
#2
We are an early stage medical device company that will be aiming for 13485 certification soon. We have implemented a paper based quality system and are in the Concept/Feasibility stage of Design Control.
Design control (7.3) has no requirements for the Concept/Feasibility stage of a medical device design - the "research" stage.

After planning (7.3.1), you only begin to apply design controls when you have determined the device inputs (Inputs relating to product requirements), and those are usually decided in the end of the concept stage.

Please note that this answer is general, related to usual Concept/Feasibility stages. If yours is different, this might not apply.
 

yodon

Leader
Super Moderator
#3
Marcelo's reply is spot on (as usual).

Just to piggy-back on it a little, it's ALWAYS a good idea to capture design decisions and rationale. I look back on various projects and see the same discussions held multiple times. Quite a waste. Having such decisions documented and available helps keep matters focused.
 
I

iso-13485

#4
Marcelo I know there are no requirements for DC during feasibility...I should have been more careful with how I worded that sentence.

For the sake of the initial question, please disregard what stage we are in.

Could anyone provide guidelines as to what type of content to include/exclude in meeting minutes specifically for

- meetings with physicians who provide input to design concepts, comment on user needs, and potential risks and hazards.

-meetings with engineers discussing design concepts

Thanks.
 

Ronen E

Problem Solver
Moderator
#5
Marcelo I know there are no requirements for DC during feasibility...I should have been more careful with how I worded that sentence.

For the sake of the initial question, please disregard what stage we are in.

Could anyone provide guidelines as to what type of content to include/exclude in meeting minutes specifically for

- meetings with physicians who provide input to design concepts, comment on user needs, and potential risks and hazards.

-meetings with engineers discussing design concepts

Thanks.
Hi,

Regardless of the standard's requirements, it's very important to capture all the above in a way that will be accessible in later stages (Verification, Validation). I would pay the highest attention to Clinicians' inputs - they are extremely valuable and can make a lot of difference later, after you become more aware of use nuances, down the development line. It'd also be extra-important when you come to address usability and conduct your risk management. Make sure to document "who-said-what" (in terms of name, position, credentials, experience, hospital / other institute), and most importantly - why do they think so / based on what. If they refer to objective evidence / published papers, that's also very important to reference.

Just off the top of my head.

Cheers,
Ronen.
 
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