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  • Cleaning of laboratory instruments

    I am wondering how to registrate the cleaning of laboratory instruments. Currently we send out a reminder but we would like to have a form in which we can see at what date instrument is cleaned in stead of eg a two monthly reminder of all instruments in a certain part of the lab. So my question really is whether such a registration is necessary or what is really required by the ISO 13485?

  • 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?”

  • 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.

  • 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?
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