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Folks,
I've come across something that may be old news to many of you - but I've just noticed it and "it" is creating somewhat of a "discussion" in my organization...
21CFR, Part 820, para 820.30(g) defines Design Validation as follows: "Design Validation....Design validation shall ensure that devices conform to defined used needs and intended uses..."
The FDA Medical Device Quality Systems Manual:
A Small Entity Compliance Guide
First Edition, HHS Publication FDA 97-4179, December 1996, Chapter 3 defines Design Validation as follows: "Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s)."
Conspicuously absent from this 2nd definition is the word "defined". If I may go on just a bit...
Using the 1st definition, an organization is responsible for defining and interpreting "user needs". Following this, we develop products which we hope will meet these user needs - again as defined and interpreted by the organization. Once developed, the design validation consists of assuring that the product meets the user needs as defined by the organization. IMHO, this approach does not assure that user needs were truly met. It only confirms that we designed and built what we think the customer wanted. Consequently the argument being posed here is that this definition (of design validation) does not require that the product be taken "to the field" in either a real-world, or simulated environment to confirm that user needs were truly met. It only requires that we confirm we designed and built what we thought the customer needed.
The 2nd definition, lacking the term "defined" would seem to obligate the organization to truly confirm that user needs were met - not just what the organization (Marketing, Engineering, etc) thought the customer required. Consequently, this definition of design validation would seem to obligate the manufacturer to perform a real world, or simulated environment confirmation.
Again, a subtle but potentially significant difference & one which I am posing to the "best & brightest" here at the Cove! Thank you for your patience!
I've come across something that may be old news to many of you - but I've just noticed it and "it" is creating somewhat of a "discussion" in my organization...
21CFR, Part 820, para 820.30(g) defines Design Validation as follows: "Design Validation....Design validation shall ensure that devices conform to defined used needs and intended uses..."
The FDA Medical Device Quality Systems Manual:
A Small Entity Compliance Guide
First Edition, HHS Publication FDA 97-4179, December 1996, Chapter 3 defines Design Validation as follows: "Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s)."
Conspicuously absent from this 2nd definition is the word "defined". If I may go on just a bit...
Using the 1st definition, an organization is responsible for defining and interpreting "user needs". Following this, we develop products which we hope will meet these user needs - again as defined and interpreted by the organization. Once developed, the design validation consists of assuring that the product meets the user needs as defined by the organization. IMHO, this approach does not assure that user needs were truly met. It only confirms that we designed and built what we think the customer wanted. Consequently the argument being posed here is that this definition (of design validation) does not require that the product be taken "to the field" in either a real-world, or simulated environment to confirm that user needs were truly met. It only requires that we confirm we designed and built what we thought the customer needed.
The 2nd definition, lacking the term "defined" would seem to obligate the organization to truly confirm that user needs were met - not just what the organization (Marketing, Engineering, etc) thought the customer required. Consequently, this definition of design validation would seem to obligate the manufacturer to perform a real world, or simulated environment confirmation.
Again, a subtle but potentially significant difference & one which I am posing to the "best & brightest" here at the Cove! Thank you for your patience!