ISO 13485 & EU MDR - Expert Advice Community

ISO 13485 Manufacturing

ISO 13485, Manufacturing of Thermometer, Ventilator, BP Measurement apparatus - what are the applicable regulatory requirements?

ISO 13485 certification

 I work for *** in the UK. I am trying to find out if I can import 4 ply face masks from a supplier in Vietnam that has the ISO13485:2016 certificate. I don't know if this is adequate or if the masks need to comply with EN or EU regulations.

Control of infrastructure

I read your article on Managing Medical Device Infrastructure and we are wondering to what level of detail and validation we have to go. For example, we have measuring equipment that requires calibration, so we create validation records for each piece of equipment, including calibration schedules and service schedules. We also have a large volume of software, for example document writing, spreadsheets, ERP systems, Finance system, etc etc etc. We also have computers for development that our development team uses, computers for service delivery that our programmes run on. The same question applies, we wonder if we need records for each computer, each desk, each software package. Can you provide any clarity in this area for us at all?

Postponing Management Review

We perform our Management Review on an annual basis and we always try to do it in May if I have to postpone it to August this year. Is that a problem?

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.