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ISO 13485 & EU MDR - Expert Advice Community

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  • Is medical device file require for a supplier ?

    If I supply plastic injection molded clips to a medical device manufacturer am I required as a supplier to have a Medical Device file for these clips?
  • What should be question for getting feedback from production of product?

    8.2 Monitoring and measurement 8.2.1 Feedback As one of the measurements of the effectiveness of the quality management system, the organization shall gather and monitor information relating to whether the organization has met customer requirements. The methods for obtaining and using this information shall be documented. The organization shall document procedures for the feedback process. This feedback process shall include provisions to gather data from production as well as post-production activities.
  • Should the company be ISO 13485 certified while outsourcing assembly service?

    HI I am a 1 man band developing a medical product and was wondering if I need to iso13485 or can I get a company who is already iso13485 to do the assembly for me?
  • Change control management in Advisera Toolkit

    Our team is making progress on transforming your 13485 doc packet into our company QMS, but they have said "there is no mention of change control management". Can you tell me where this is in the packet?
  • Is vendor agreement mandatory for ISO 13485?

    Regarding vendor agreements in ISO 13485 2016
  • What form of signature does ISO 13485 accepts

    The organization I work for is considering ISO 13485 certification in the future. Does ISO 13485 require hand written signatures or are electronic/digital signatures acceptable as long as we use a formal validation of the system for electronic signatures?
  • Exclusion of clauses for ISO 13485 for small business

    1. I have been told that small businesses of less than 5 employees can be excluded from some areas of IsO 13485. Can you let me know what these are please?
  • Organization of folder using Advisera template

    Would you advice to build the structure of the folders like you have provided (ex. 00 is the Procedure for Document and Record Control, the second is folder 01 the Project Plan, the next folder is the Quality Policy) or to have a structure that corresponds directly to ISO 13485 ex 4. Quality Management system, 5. Management responsibility, 6. Resource management etc) and store there the corresponding processes? What is more recommended for notified body audits?
  • Is ISO 13485 applicable to a non-profit organization?

    We are a non-profit organization that ships supplies and equipment to international partners throughout the world. We have recently been asked to provide documentation to prove our used/donated medical equipment meets ISO 13485 certification requirements. How can this be accomplished?
  • Is advisory notice applicable to a subcontract manufacturer ?

    Does Advisory Notice is applicable for the organization that produce product for other company (sub contract). should we create a procedure regarding this? Our organization not supply to end customer, but delivered to Main company first.
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