ISO 13485 & EU MDR - Expert Advice Community

Change management

we are being evaluated as a potential supplier. The customer provided us with an extensive questionnaire.

An entire section is related to change management. From what I understand, the change management as such is not part of ISO 13485.

I believe it is an FDA requirement.

How should I answer the questions related to the change management without losing the trust of the customer?

Or should I just create a new procedure?

Advanced notification of change

What should be a typical timeframe for advance notification of change to our customers?

ISO 13485 for trading of medical devices

Dears, I'm working currently in a company that export and import some medical devices (without manufacturing ), is it eligible to be certified with ISO 13485?

Distributor vs Supplier quality agreement

Some of our products critical to the medical device are outsourced through the distribution chain. When discussing the Quality Agreement, do we ask for one from the distributor or the actual manufacturer?

We sent one of the agreements to the distributor, and he answered (and, frankly, had a point) that since he is not a manufacturer, this is not a binding document, applicable to his relationship with us.

How to deal with distributor vs manufacturer quality agreements? Who shall provide us with the quality agreement?

Preventive action

Is redesigning a faulty, non-conforming product a preventive action for future products or a corrective action for the faulty one?

Purchase (vendors) scorecards

Good morning,

While working on the purchase procedure, I noticed, that the vendors scorecard is a good way to track the quality of the purchase.

However, I dont see this particular document to be used by our company and I don't want to create anything that will not be ultimately used by my co-workers.

Is there any other, more simple way, to comply with the ISO 13485 Purchasing but avoid the complication of a vendor scorecard?

Thanks.

Business Development and Sales - core process?

Is it correct to place the "Business Development and Sales" under the core company's processes? For now we have it under the Management Processes, but thinking about moving it. Does is make sense?

Thanks.

GSPR

Regarding the GSPR: is a Procedure for identification of the General safety and performance requirements needed?

Information about undesirable event and conducting investigation

Could you please answer several questions:
1) through which communication channels does the user send a message about an undesirable event to the manufacturer of the medical device?
2) in which cases the competent authority itself conducts an investigation?