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ISO 13485 & EU MDR - Expert Advice Community

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  • Do we need ISO 13485 if we have IEC 62304?

    Do we really need ISO 13485 or is it just icing on the cake? We have to have IEC 62304.
  • Management review questions

    I would like to ask two questions regarding the management review. 1. risk policy that is referred to in the template - what is this exactly? is it the risk management policy according to ISO14971 or is it a general risk assessment for the policy? how exactly can it be evaluated during management review? 2. the matrix of KPIs - is it ok if timewise it is approved during the first MB meeting, or does it need to be prior (in our case, 3 months prior when the SOP was established) and presented to the management for review?
  • Most efficient steps in regulatory pathway to introduce class III implantable device

    in order to introduce a class III implantable device manufactured in our own startup company, what is the most efficient steps in the regulatory pathway you would you advise? Eg Establish QMS - compile dossier of pre-clinical evidience - seek regulator approval for phase I safety trial - CE mark product - ISO13485 certification?
  • PHA risk evaluation

    1. In the document ISO 13485 & MDR Integrated Documentation Toolkit – does MDR 2017/745 correspond to all 2017/746 requirements? 2. I need to create a PHA risk evaluation analysis for my medical device (photometer). I do not think that in this toolkit there is a template for PHA risk evaluation for an electrical device. Is it possible to request this document from you or to buy it separately?
  • Requirement of compulsory annual health check-up of employees

    Is there a requirement of the compulsory annual health check-up of employees, as per ISO 13485?
  • Inquiry for missed document

    My company was recently adopting your ISO 13485 system. Could you please check if the documents we get from you complied with MDSAP with the USA, Canada, Japan, Brazil, Australia and Europe (MDR) involved?
  • 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 ?
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