ISO 13485 Section 7.3 Design & Development Exclusions

A

Acchi Larka

#1
Dear Friends,

I know my questions can seem strange at times...maybe this time too. Here is a scenario: My client is seeking 13485 registration but wants to take an exclusion as it pertains to Design & Development of new medical devices.

But here is what happens. My client receives a concept on a napkin or scratch paper. Then, takes the concept and mocks up to a scale of choice, makes a crude quasi functional protptype mainly from off-the-shelf stuff from various stores. The mock up is sent to his client who is the idea originator who reviews and approves the concepts of the mocked up device and then contracts actual design engineering firms to actually build to specified requirements a new medical device for sale internationally. After the devices are developed they come back to my client who assembles, tests and distributes the new medical devices for the holder of the patent. Whew! Can he actually exempt his business from Section 7.3 Design & Development when he's doing physical conceptual design?

Thnaks!

Acchi Larka
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Dear Friends,

I know my questions can seem strange at times...maybe this time too. Here is a scenario: My client is seeking 13485 registration but wants to take an exclusion as it pertains to Design & Development of new medical devices.

But here is what happens. My client receives a concept on a napkin or scratch paper. Then, takes the concept and mocks up to a scale of choice, makes a crude quasi functional protptype mainly from off-the-shelf stuff from various stores. The mock up is sent to his client who is the idea originator who reviews and approves the concepts of the mocked up device and then contracts actual design engineering firms to actually build to specified requirements a new medical device for sale internationally. After the devices are developed they come back to my client who assembles, tests and distributes the new medical devices for the holder of the patent. Whew! Can he actually exempt his business from Section 7.3 Design & Development when he's doing physical conceptual design?

Thnaks!

Acchi Larka
Let me ask you a question please:

If these were 2 separate companies -- one creating crude conceptual models, and the other contract manufacturing medical devices -- would you have said that the first should maintain 13485/7.3 compliance? What would such a company be selling - a service? A concept? An object? And, is it related to medical devices?...
 

somashekar

Staff member
Super Moderator
#4
Dear Friends,

I know my questions can seem strange at times...maybe this time too. Here is a scenario: My client is seeking 13485 registration but wants to take an exclusion as it pertains to Design & Development of new medical devices.

But here is what happens. My client receives a concept on a napkin or scratch paper. Then, takes the concept and mocks up to a scale of choice, makes a crude quasi functional protptype mainly from off-the-shelf stuff from various stores. The mock up is sent to his client who is the idea originator who reviews and approves the concepts of the mocked up device and then contracts actual design engineering firms to actually build to specified requirements a new medical device for sale internationally. After the devices are developed they come back to my client who assembles, tests and distributes the new medical devices for the holder of the patent. Whew! Can he actually exempt his business from Section 7.3 Design & Development when he's doing physical conceptual design?

Thnaks!

Acchi Larka
Your client's client or the idea originator is the design owner and your client is the contract manufacturer who manufactures per the final issued specified requirements a new medical device for sale internationally.
We do a lot of this for our customer as well, and we have kept the design and development outside the 13485 QMS and successfully. Many variants of a medical device happens this way where we are the design partners but not design owners. We do many such stuff for our customer based on our manufacturing knowledge which builds on our customer's idea for a new device. We also end up manufacturing the same when the final design flows down to us for manufacturing.
 
A

Acchi Larka

#5
Thank You. Your company's experiences sound just like what my client is getting into. Your comments are greatly appreciated.

Acchi
 
A

Acchi Larka

#6
Thank you for your reply. To answer your questions, yes my client is making the crude conceptual models and in some cases physical improvements to functional diagnostic devices after the design originator approves the conceptual model...as a service. Once the deisgn is finalized by the design owner, my client is then responsible to fabricate, assemble, test, and distriubte the devices globally...as well as service particular types of devices. It's more than a prototype shop and this is where I get confused about his intention to take 7.3 as an exception.

Thank You,

Acchi
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Thank you for your reply. To answer your questions, yes my client is making the crude conceptual models and in some cases physical improvements to functional diagnostic devices after the design originator approves the conceptual model...as a service. Once the deisgn is finalized by the design owner, my client is then responsible to fabricate, assemble, test, and distriubte the devices globally...as well as service particular types of devices. It's more than a prototype shop and this is where I get confused about his intention to take 7.3 as an exception.

Thank You,

Acchi
[Assuming this was addressed at my post above]

The main point I was trying to make was that the fact that this entity (=your client) takes on 2 different roles in two (separate, IMO) stages of the product life cycle seems to cloud the situation a bit. Therefore I was recommending, in order to get more clarity, to separate the issue into 2, as if those were 2 different entities. The fact that there's another entity (the engineering firm) that completely gets between those 2 stages makes it rather a clean cut, IMO (if that is really the situation; I can only rely on your description as I understand it).

I believe there's no dispute re. the applicability of 13485 (relevant sections) to the contract manufacturing activities and onwards (distribution, service etc.). Now all that remains is to address the activity of creating a crude prototype from an idea. The fact that the same entity is involved in other activities (not directly related), and draws expertise from them which allows it to perform better in making the prototype, is less relevant IMO.
 

Marcelo

Inactive Registered Visitor
#8
Your client is in the US? Can he exclude Design and Development in the FDA framework? If so, he can do it in ISO 13845. If not, he can't.

For 13485, you can only exclude if the applicable regulatory requirements permit it.

Anyway, the conceptual phase of design is usually not controlled by design controls requirements in standards and regulations (design input is defined after choosing a concept to advance to detailed design).
 
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