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  • Requirements for ISO 13458 implementers

    "I am offered to take on a role in certifying our company to ISO 13458. I do have extensive experience in ISO 9001:2015 and I have had the training from AQS ANSI certificate. Do I need to take a course to transition our new company or is there a feasible approachable way to do so at minimum cost?”
  • Infrastructure and Work environment

    Hi, We are a small company and we have a subcontracted production as well as a subcontracted R&D. Can we exclude from our QMS 6.3 infrastructure and 6.4 work environment and contamination control ?
  • Coding Documentation

    Is it required by the standard to have a coding system for your documentation? Before we started our ISO 13485 certification, we would organize the documents by folders and name the documents according to their contents, then revisions and sometimes dates. For example, "1 Quality (Folder) > Quality Manual Rev 03.docx (Document name). Will this be satisfactory for our organization and control of documents?

    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

  • 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.
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