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  • Contract Review per ISO 13485 sec. 7.2.1, 7.2.2

    Please advise if the requirement specified in these sections enforce using a dedicated form (hard copy or electronic) , having the ability to show that all requirement lay out in these sections have been reviewed - meaning dedicated checkboxes . e.g. product requirement are defined and documented , no regulatory constrains, no open user training needs, organization have the ability to meet defined requirements etc... . Dose simple approvals of operations and QA/RA without using these check boxes is enough to fulfil standard requirement.

  • Difference between 3.10 Release in production/ market and 3.12 Transfer to production

    Can you please clarify the difference between 3.10 Release in production/ market and 3.12 Transfer to production?

    Is this relevant for Software as medical device also?

  • GMP accreditation

    I have been asked to help a company with ISO 22716:2007 GMP accreditation.

    Unfortunately, my experience is within the Pharmaceutical industry only working with the TGA, APVMA, and ACO for 25 years + so I have no knowledge of what is required to be ISO accredited.
    I visited the company yesterday and it would be starting from scratch as they just make all-natural, non-toxic, vegan skin care products which are filled, packed, and sent straight out to online customers only.
    There is no testing of raw materials, packaging, or finished product.....
    They have no documentation at all established and I was wondering if they need to be ISO 9001 Quality Management as well as being accredited for ISO 22716 GMP compliant for Cosmetics?

    The company is looking to expand into the USA market.

  • Difference between ISO 13485 and EN 14683:2019

    What is the difference between ISO 13485 and EN 14683:2019?

  • Timeline and cost associated with getting ISO 13485 certified

    1. Understanding the timeline and cost associated with getting ISO 13485 certified. 2. And can we begin selling earlier if we are getting CE Mark via self-certification?

  • ISO 13485 implementation

    When a company is going for IS 13485 certification, is it mandatory to go for ISO 9001

  • What to exclude from Procedures and/or Quality Manual?

    We will be NOT be designing or making medical devices. We will be molding plastic components that do not require sterilization. What should we exclude from our Procedures and/or Quality Manual?

  • ISO 13485, clause 4.2.3 Medical Device File

    Does a service company who is only transporting medical devices from point a to point b, have to have a Medical Device File, ISO 13485, clause 4.2.3? I won't think so. Isn't this not applicable since they are only transporting goods from point A to point B.

  • 13485 arrangements for Proof of Concept work

    We have a couple of medical device products already registered with the MHRA and submitted to FDA 510K Approval but are now getting into medical device proof of concept mini projects and I want to minimize documentation requirements as these projects are short term and do not become devices. Our current medical device project paperwork is too cumbersome for these and I wonder if there are minimum requirements laid out by the standard.

  • 21 CFR 820 / ISO 13875

    We are registering with the US FDA. I have determined if I get compliant with ISO 13875 I can pretty much meet the requirements of 21 CFR 820. It appears your company is not based in the US. I would like to use it to build our QMS. At some point, we will be attempting to bet ISO 13875 certified but at this point it is not required. Please advise. Thank you.
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