ISO 13485 Clause 7.3.3 a)

C

CMiller

Registered
#1
#1
Hi,
I am trying to design a template for our future design input meetings. I was having trouble defining the different requirements that are stated in line a. It states that " Inputs relating to product requirements shall be determined and records maintained. These inputs shall include: a) functional, performance, usability and safety requirements, according to the intended use." It does not define the difference between a functional requirement and a performance requirement. Is there a definition that I missed?
 
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T

Tidge

Trusted Information Resource
#2
#2
I can offer some guidance from other areas. YMMV.

I would treat functional requirements as those that shall be verified.

I would treat performance requirements as those that shall be validated.
 
Y

yodon

Leader
Super Moderator
#3
#3
The list of requirement types is mostly a tickler to get you thinking about the breadth of requirements needed for a safe and effective product.

I believe it helps if you first have user needs defined (where things like speed, accuracy, ease of use, etc. are established). Then let engineering provide their answer to how those user needs are met. These will likely include both functional and performance requirements (as well as the others in the list).
 
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