ISO 13485 & EU MDR - Expert Advice Community

Product requirement Review record

We are a small company, but many hospitals - companies and private persons are sending a request for a quote or price information on our product.

I am now looking at chapter 3.3 Receiving and recording customers request.

My question is if we by 1st. contact should fill in the appendix 1 Product requirement Review record?

The reason for my asking is that we might have a rate of app. 50% of the complete numbers of quotes we are making that we do not get any reply when contacting them. Sometimes it is only a request to see if pricing is competitive. So my thought was not to make this record until we know that this is a more solid contact to proceed with.

How does this comply with the ISO13485?

Supplier qualification

I'm looking for information regarding supplier qualification to be compliant with ISO 13485

Application of integrated ISO 9001 and ISO 13485

I would like to have a question: some of medical devices are applying both ISO 9001 and ISO 13485, could you explain me what are the reason?

Calibration Intervals

Hello I am looking for rationale for calibration due date being set at end of month.

ISO 13485 and finished medical device from a supplier

Dear, i have this question. A company is manufacturing and marketing a class II medical device in Europe. This manufacturer outsource the medical device (liquid eye drops) from another company. The supplier supplies the substance "finished" and the manufacturer only makes the asepthic filling and packing. Because the supplier is producing the final product (except the packing) in bulk should they be ISO13485 certified ?

ISO 13485 implementation

My company plans to implement ISO 13485 on the base of the Quality Pharmaceutical System(GDP). Could you advise please which first steps have to be for that implementation?

Manufacture of Hospital Beds

Which standard applies to the manufacture of hospital beds?

Medical device Auditor

I have a question related to auditors. What is the eligibility to become a medical device auditor

Question on ISO 13485 & MDR

The reason of my interest is not that that I want or must have the ISO13485 certification, but my supplier (a medical device manufacturer) for whom I sell their devices already for over 10 years, is suddenly asking me a list of all my clients, as they say they must contact my clients in view of ISO13485 & MDR…?

In my belief, this is not compulsory for them to do.

Are you in agreement with me?

As their rep. and sales office I can contact of course my buyers on their behalf, IF at all needed??

Implementation of ISO 13485

Hello! My company is a small contract engineering group that offers medical device development services. Since we are purely R&D (no manufacturing) does it make sense for us to implement ISO 13485 in your opinion? Thank you for your time.