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ISO 13485 & EU MDR - Expert Advice Community

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  • ISO 13485 certification

    My question is for a company working on user-friendly comprehensive software that can help hospitals or doctors to record all medical data. If they plan to go for ISO 13485 implementation, is it must for all employees to be trained on ISO 13485 and the hired QA person for this role is requires any special qualification other than ISO 13485.

  • Evidence for Product realization

    We do not manufacturer medical devices/equipment, but we do service and repair them. We are looking to get ISO13485 certified as this will help with being compliant hopefully to the new MDR coming out in May 2020. Section 7 of ISO13485 is product realization. As we do not manufacturer but service, do we still need to provide evidence for this section?

  • Facilities Validation Master Plan

    Can somebody advise how to develop a Facilities Validation Master Plan for a new R&D and technical support facility to comply with ISO 13485?

  • CE-MDD marking, NBOG Scope Expression and GMDN code

    We are a medical device firm and we design and produce spinal implants. We are going towards CE-MDD marking. I'm unclear if we produce class 2b or class 3 medical devices or both. Also, we need to pin down the NBOG Scope Expression, Rule and correct GMDN code. Your help will be greatly appreciated!

  • Changes in kit manual or kit inset

    I work for a company in the field of PCR based Molecular Diagnostic Kits.The Company is ISO 13485:2016 certified. I have a question regarding the manuals of the kits. If we do some changes in our manual or update our kit format, whether that will come under version change or simple amendment changes. How we should document it?

  • Label printing validation

    Need support for label printing validation.

  • Validation of Computer Software and GAMP 5 Guide

    I have been reviewing your “Procedure for Documentation and Validation of Computer Software”, and want to know if it meets the ISO 13485 Computer System Validation (CSV) requirements?  Also, does it take the GAMP 5 Guide (Compliant GxP Computerized System) into consideration?

  • Validating Conformio software

    Hello, I have a question whether Conformio software has to be validated as per ISO 13485:2016 requirements, Clauses 4.1.6 and 7.5.6, and if it has to be validated what is the best way to do it?
  • Do people working in departments excluded from scope have to be trained for QMS?

    I have a question regarding how to decide if a person needs to be trained in various parts of a QMS set up for 13485:2016 compliance. People processing medical device have to be trained. But what about a person for example in marketing, who has nothing to do with any part of the work affecting product quality. Do people working in departments excluded from the scope of the QMS (for example finance, legal, marketing) have to be trained in various procedures contained in the quality manual?

  • Would becoming ISO 13485 compliant benefit customers more than ISO 9001?

    We manufacture machines that are not subject to FDA oversight. However, our customers use them in an FDA regulated environment. Would our becoming ISO 13485 compliant benefit our customers more than an ISO 9001 certification?
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