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ISO 13485 & EU MDR - Expert Advice Community

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  • MDSAP

    To obtain the MDSAP certification, should we have both ISO 13485 AND 9001, or just ISO 13485?
  • Requirements for infrastructure

    Regarding the ISO 13485:2016 PR 05 Procedure for Infrastructure and Work Environment: 95% of our business is repair of surgical drills and saws. The other 5% of our business is contract manufacturing for OEM surgical device makers. We do not manufacture complete medical devices in our facility. We do not have clean rooms, and we don't test our air quality for microbiological or particulates. What all is actually required in our procedure as far as the standard is concerned?
  • How to start ISO 13485 implementation project

    How to start the project of ISO 13485 after getting the management approval?
  • Content of the medical device file

    Setting up the medical device file under the new 13485 have added ISO certs and Manufacturers Instructions is there anything specific I should be adding to it.
  • Software validation for raw material supplier

    Hi,
  • Declaring compliance without certificate

    Hi Strahinja,
  • Software validation in medical device

    We are sitting for our ISO 13485:2016 shortly, and wish to know how we can validate our software for inventory management? Thanks in advance for the feedback.
  • Australian Standards

    My question is about the similarities of ensuring the ISO 13485 is applied on the AS NZS 3551.
  • FDA 21 CFR Part 820 vs ISO 13485

    I am in charge of implementing FDA 21 CFR Part 820 for my company. We may also be selling our product in Europe in the future. Would complying with ISO 13485:2016 meet all FDA QSR requirements?
  • Exclusion of requirements

    Thank you for your excellent product. We are an ISO 9001:2015 certified company, and primary business function is the repair of surgical drills and saws used in orthopedic and oral surgeries sent to us at our facility by the user. We also do a small amount of contract manufacturing for orthopedic companies. At this time, nothing that we make or repair is implanted into a person during procedures; we only repair the tools used to perform the operations. There are several sections in the 13485 standard that we do not do; can you tell me if we are exempt? I am still trying to wrap my head around all of the provisions in the 13485 QMS and all of the required procedures.
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