ISO 13485 & EU MDR - Expert Advice Community

Class II device packaging services, CE mark

I work for a contract packaging house that is ISO13485:2016. I have a customer that has a Class II device they would like to package with us. They will be getting the item certified to EU standards to get the CE mark for it. The question I have is, does our 13485 ISO cert cover us to support the customer on this? Since we do not hold the 510k, but would be a part of the supply chain, is any additional certification needed for us to primary and secondarily package this Class II item?

ISO 9001:2015 versus ISO 13485:2016

The document Clause by Clause explanation of ISO 13485:2016 states that ISO 13485:2016 discards some of the requirements of ISO 9001:2015, but the ISO 13485 standard Table B.2 identifies an ISO 13485 clause corresponding to each ISO 90001 clause. What are the ISO 9001 requirements that have been discarded from ISO 13485?

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