ISO 13485 & EU MDR - Expert Advice Community

CE Marking and Major NCRs

If a CE marked product gets a major NCR from a notified body, does that mean you have to cease selling it until the NCR is addressed?

I am just trying to understand if selling a CE approved product is legal or illegal to sell with known major NCRs against it?

List of certifying bodies for ISO 13485

Thanks for the kind Webinar. Can you please suggest any certifying body for ISO 13485 in Germany?

Certification of QMS

Thank you for the webinar, it was useful.
But I would like to consult a bit more….Could I?

This is regarding certified QMS according to ISO 13485.

MDR does not have indication that QMS must to be certified, there is indicated minimal requirements for  QMS. Isn’t it enough?

In *** we have accredited notify body, and they told that there is no information or indications about certified QMS, we are new to this field, and as I understood form your webinar this is new changes, and that there still misunderstandings possible.

If you would be able to advice me I would be really grateful.

Need for ISO 13485 certification for PRRC

I want to offer my service as PRRC, related to the MDR. Do I need (would it be useful) to have ISO 13485 Certification?

Internal audit schedule

I am working on a new internal audit schedule, now I was advised to start a 3 year cycle, auditing the most important processes first.

Nice, for me all processes feel important. There certainly is an kind of standard perception on the importance of processes / ISO13485 paragraphs.

Are you able to help out and guide me in this one?

Writing quality SOP for work infrastructure

Medical Device File

Is Medical Device File (ISO 13485:2016 requirement 4.2.3) called Technical File in MDD 93/42/EEC, is it the same file?

FDA

Our company is ISO 13485:2016  certified. We have a new customer who wants us to manufacture and pack hearing aid. As you know FDA doesn't require 510K for Hearing Aid, but the customer wants us to register with FDA. 

Without 510K what will be our company's responsibilities for the product if we decide to register with FDA.
Please advise.

Thank you for your help in advance