ISO 13485 & EU MDR - Expert Advice Community

Which ISO standards are mandatory to purchase as an official version?

I would like to find out which ISO standards are mandatory to purchase when implementing ISO 13485. There are many different ones, and quite frankly, expensive. I understand that ISO 13485 or ISO 14971 /24971 must be purchased as an official version, but what about others?

Thanks.

External auditor for contamination for warehouse environment

my interest is what does an external auditor look for contamination for warehouse environment

MDR Device Labelling

Gxp versus 13485

I am working an a pharma company with haveing a some combination products - medical device with pharma. We want to have in addition to GxP System the 13485.
Could we implent the 13485 with a mixture of good running GxP SOP (e.g. change control) and new ISO SOP?s

Measuring Equipment

Hello,

is the definition of the measuring equipment in ISO 9000 applicable for ISO 13485?

“Measuring equipment” is defined in ISO 9000 as “measuring instrument, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process”.

Could you elaborate on what type of equipment we must take in consideration during the implementation process?

Thanks.

Matrix of Key Performance Indicators

Is the Matrix of Key Performance Indicators from Procedure set 23 different for every Management Review, or is it a set of all KPIs in general?

ISO 13485/MDR certification

 We are preparing for the certification according to ISO 13485 and MDR.  Our company has 14 meddev families. Is it possible to limit the scope of the certification on 2 families only or we HAVE to have all 14 families covered (risk file, tech file, etc)? So technically we would use the CE mark on two products initally and move forward.

Device classification map (questionnaire) for MD/IVD

I'd like to know if we need, for the certification puroposes, a filled device classification map (questionnaire) or if the result of classification is enough? In order words, is the chosen MD class enough or we need to show how we got to the specific MDR/IVDR class?

To clarify bit more: we used an online software to classify the MD. We got the result, but not the path with questions and answers.

Thank you,

L.

Customer complaint - reporting to the authorities

Would it make sense to move the Registry of Reports to the Authorities from section 08 Customer Complaints and Feedback to 15 Non-conformities? Or make a connection in the procedure between the Report to the Authorities and 15 Non-conformities section?

I am still unsure which complaints/non – conformities/ adverse events we should report.

I understand that a complaint can result in non-conformity, and non-conformity could result in some adverse event.

Do I see it correctly?

Is ISO 13485 certification applicable for company which provides eQMS dedicated to medical device industry clients?

I'd like to know if ISO 13485 certification is applicable for our company which provides an eQMS dedicated to the medical device industry clients, though our eQMS is not a medical device