Medical Devices: Product/Production Quality

[GerBar]

Dear all,
Situation: a medical company (the developer) develops a medical device class IIb for the EU market (MDD) but is not yet ISO 13485 certified but will be very soon. Production is outsourced to a company (the producer) that is ISO 13485 certified.

Now the full-compliance testing (EMC and Safety) has been planned on the first batch (3 pcs) but the producer cannot fulfill all 13485 production requirements yet for this batch. (This has mainly to do with not having all technical documentation ready.)

After that the developer will be 13485 certified.
Then the second batch, that will be offered for sale, will be produced under full 13485 production requirements.

My question: is this allowed according to the MDD and ISO 13485?

Or to put this question in another format: is it allowed to get approval for product quality (EMC & Safety) before approval/validation of Production Quality?


cheers
GerBar

 

[jezh09]

What exactly is missing from the first batch? What do you mean by technical documentation? You will still need traceability and records to show that the batches used in EMC and Safety testing created using final production specifications and acceptance criteria.

It's okay to validate the production processes concurrently, but if it fails validation and you need to change your production processes/materials/design, you will have to use a risk-based approach to decide what else will have to be re-tested (EMC, safety, etc.)

 

[Mark Meer]

Hi GerBar, and welcome to the forums!

Yes, this is acceptable. But you should be prepared to make the case that the units tested are the same as subsequent production units. If the company is operating a 13485 system - even though not yet formally certified - then they are presumably exercising an acceptable degree of process control as is. To whatever degree there are gaps, simply document an assessment that these don't fundamentally affect the units tested, or the types of tests being done.