A
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
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