Design Transfer

GOOD MANUFACTURING PRACTICE (cGMP) SIX SIGMA
1

Hello,

Regarding the Design Transfer phase in Medical Devices Industry i would like to know:

  1. Usually what kind of documents are a part of these phase?
  2. How long usually it takes?
    3? Being Design transfer a process between verification and validation phases, when exactly should this phase start?
    4? What is the relation between Design transfer and the CE mark?
  3. What is the relation between Design transfer and the EHS (Environment, Health and Safety)?

Thanks

2

This has been a less-than-clear area for me as well so I hope to see a good discussion. Below are only my thoughts / approaches (have passed muster so far).

  1. I have just written a memo to file essentially acting as a checklist to summarize / confirm that the DHF is complete, V&V is complete, production specifications have been baselined (accepted), the DMR is baselined, a DHR outline has been established, and all labeling, packaging, and shipping has been validated. If you have a requirement for labeling translation, maybe confirm that as well. So only 1 document is written but it summarizes many others.

  2. The memo itself didn’t take long; the work leading up was the challenge.

  3. I wouldn’t consider design transfer a process between verification and validation at all! The regulation says that design transfer ensures “that the device design is correctly translated into production specifications.” In ISO 13485, there’s a note stating “Design transfer activities during the design and development process ensure that design and development outputs are verified as suitable for manufacturing before becoming final production specifications.” So neither indicates timing and in fact, 13485 indicates a process versus a milestone.

  4. None that I’m aware of. Based on the note in 13485, though, it’s reasonable that some evidence of the activities occurring would be expected. (And of course, they do occur in the form of production specs, assembly instructions, etc.).

[6]) None that I’m aware of.

Would be interested to hear how others have approached Design Transfer.

3

Thanks for responding.

I have other comments:

  1. Should Design Transfer be done after or before CE mark?
  2. Do you recommend any reading? I have checked (among others):
  • John H. Linehan et al; Study on Medical Device Development Models Final Report Prepared InHealth – The Institute for Health Technology Studies, Stanford University, 2007
  • Jose Justiniano & Venky Gopalaswamy, Six Sigma for Medical Device Design, 2005

Thanks

4

Typically, the CE mark is obtained prior to production (since it affects labeling). So I would say typically design transfer is done after the CE mark is obtained. If you get the CE mark after design transfer, you’ll need to cycle through another design transfer iteration to incorporate labeling changes, etc.

Sorry, no recommendations on reading materials.