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  • Clauses that require records

    Regarding al the ISO 13485 clauses:
    -Which ones are the ones that require records? 

  • Checklist for pre-/post site inspections

    We are moving our cold storage (medical diagnostic kits and reagents) from one site TNT to a new site Fedex.

    Do you have a checklist or can you give me tips on what to put in my checklist for the pre-/post site inspections before and after the move?

  • Non-applicable clauses for supplier of component for medical device

    As a supplier of component for medical device, which clauses will be not applicable for us?

  • Differences between medical device certifications and ISO 13485

    What are the main differences between medical device certifications and ISO13485?

  • Procedure for the Software Life Cycle

    I have vigorously started to implement the QMS in our company. I see that you do not have a separate procedure for the Software Life Cycle… Don’t you guys have such a template?

  • 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?
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