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  • Rule 19 nanoparticle antibacterial coatings

    When does Rule 13 apply and when does Rule 19 apply? We have a nanoparticle coating for endotracheal tubes.
  • Purchasing information

    The requirements that ISO 13485 describes with regards to supplier agreements is: 7.4.2 "Purchasing information shall include, as applicable, a written agreement that the supplier notify the organization of changes in the purchased product prior to implementation of any changes that affect the ability of the purchased product to meet specified purchase requirements." For some further information and background, refer to ISO13485 Section 7.4 Purchasing. That is mostly the extent of the ISO/FDA medical device requirements, to my knowledge. Beyond the ISO requirements, we want to think about what else might be critical so we can use this agreement, hopefully for a while with new suppliers. We may want to consider shifting some of the liability in the agreement; for example, if we determined that there was a bad batch of load cells that failed after 1 week of usage in the field, where would that liability fall? We would like a Supplier Agreement that includes the above, and remains somewhat general so we can use it with all of our suppliers with only minor changes required. We have suppliers that range from label makers to load cells to steel sheets, for some more general background.
  • In Vivo Test Requirement

    I have a question about in vivo test requirement. As you know our product *** is class-III and we need if in vivo test is mandatory for bio-compatibility. If you can answer this we will be glad.
  • Issue with self-certification process  for class I product according  to MDR

    I have an  issue with MDR certification for which I would like to get your advice. The issue is regarding to the self-certification process  for a class I product according  to MDR; the manufacturer being part of the EU. Need for an UDI and basic-UDI, notification to the national authority where  the manufacturer is established, declarationof conformity and then ?
  • Excluding Clause 7.3 (Design and development) from QMS

    in what cases is it possible to exclude Clause 7.3 (Design and development) from QMS?
  • Questions Regarding Clinical Evaluation

    We have noticed that our current clinical evaluation report does not meet the MDR requirements due to unsatisfactory documentation. Eventhough all clinical tests and results are good enough for proofing the product usage  the consultant company did not properly documented as regulatory requested format and contents .So we need to reorganize CER report  and need a new company/individual  to assist us. Our intention is to work with a competent and reliable agent. In addition to CER work we also need to rework on some tests(Biocompatibility). So I need your guidance and recommendation for selecting a test center and CER process.Do you know any source for recommending us?
  • 4.2.4 and 4.2.5

    I had one question. What does this verse mean exactly for 4.2.4 and 4.2.5 on ISO 13485? The organization shall retain the records for at least the lifetime of the medical device as defined by the organization, or as specified by applicable regulatory requirements, but not less than two years from the medical device release by the organization.
  • ISO 13485 toolkit ref 11

    I wonder if you can give me some guidance on ISO 13485 toolkit ref 11 procedure for production and service provision. As we are a distributor the only part I seem able to answer on here is 3.3.7, because I can relate that to the batch and serial tracking once we have received the goods through to their delivery at customer. I know the QMS says various parts of 7.5 can be excluded. But I am not sure if need to fill in more in order to be complaint?
  • MDR requirements for IFU

    a small question, may you help me: I searched all and didn't find: are there sume restrictions or requirements regarding font size used for IFU?
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