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Question

2 weeks ago

Quality and regulatory through innovative solutions

Why is FDA accepting 510(k) for implants with no usability or biocompatibility?

I'm new to my orthopedic implants and associated instrument company and inherited a 510(k) in review. In this 510(k) and those cleared in the last year, we had no discussion on usability 62366-1. We also didn't discuss evidence for biocompatibility beyond materials standards, and predicate comparison.

That was not the case in my previous company (external communicating devices, short-term).

Can you help me understand why these devices are being treated differently?

2 weeks ago

Clément Vallois

Project leader - Medical devices development guided by user satisfaction and patient safety

Finished good article codes

Dear colleagues, what are your "tips and tricks" to limit the number of article codes for your finished products?

How do you manage the different power cords, languages for software interface, languages for IFU, duration for authorization time, labeling differences, and more?

Thanks in advance, and best regards.

4 weeks ago

Minakshi Mohanty

Medical Device Engineer (Research & Development)

How to Design Protocols?

There are many resources available on QSR, design controls and standards, etc; but there is a gap in understanding how these protocols should be designed to follow these regulations.

Let’s say I am designing a PCB and have to write a protocol to test it. I would include measuring voltages and current at different stages.

But there is much more to consider, even before I plug in the device (like shorts and loose solder connections). Many companies have a team to take care of this, but in a start-up that may not be practical.

My question: What's a good approach when just starting out in protocol design?