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  • 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.
  • Questions on internal audit

    I have a question regarding the Internal Audit procedure – is it common practice for the internal audit to be performed more than once a year?
  • Defining LOT number for medical device

    I am currently helping a medical device manufacturing to get ISO 13485 certification and we are now currently in the Identification and traceability stage - how to create LOT number? I would like to get more information on that.
  • Auditing documentation requirements for ISO 9001 and ISO 13485

    Please advice me in may concern. We are in process of re-certification audit for ISO 9001:2015 and ISO 13485:2016 but there is a difference clause in Documentation for ISO 9001:2015 it in clause 7.5 Documented information but in ISO 13485 its 4.2 Documentation requirement. What clause shall we use for internal audit? Clause 7.5 of 9001:2015 or Clause 4.2 of ISO 13485:2016.
  • Content of the Design History File

    Can you please give me an example to constitute a design file, I need to have at least a summary in accordance with the new requirement of the standard iso 13485.
  • IAF MD 9, ISO 13485 and ISO 9001

    Is the 13485 will get a MD9 jointed with the 9001 or do they remain 2 separate entities (for example companies wanting to have both 9001 & 13485) in relation to term of audit duration? With the new standard 13485:2016, it's trying to be more inclusive and englobe the product from design to production, selling and post market. Do distributors of medical device have to comply to the new standard (if previously 9001)? Or is it just a nice to have and can keep distributing under a 9001?
  • Risks SOP, Medical Device File and auditing ISO 13485

    I'm currently trying to implement ISO 13485:2012 for the first time and we're planning to have the assessment in few months – I'm also implementing the new ISO 9001:2015 edition so working with both the new and old clauses.
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