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Question
2 days ago
Minakshi Mohanty
Medical Device Engineer (Research & Development)

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?

4 days ago
Ong Kean Seng
Senior Manager Regulatory Affairs at InQpharm

I just came across a legal manufacturer in EU with CE Certificate granted to their devices but without having ISO13485 certificate.

I ran through MDD 93/42/EEC and it seems there is no stated requirement that a legal manufacturer needs to obtain certification for their QMS. That is, as long as their QMS is in accordance to recognized harmonised standards, and subject to an NB assessment/audit.

Do you arrive at the same conclusion, that they'd be able to get CE certified in this situation?

5 days ago
Kyle Vlasak
VP Sales and Marketing at Vonco Products LLC | Job Search Coach and Author

Polyolefins have been shown to be safe alternatives to PVC's widely reported risks.

However Polyolefin films make up only a small percentage of liquid tight medical bags in the US with shapes and fitments.

Is it because of the sizable investments already made, or not knowing how to make with Polyolefins in scale?

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