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  • Best practices in utilizing old clinical studies

    What are the Best practices in utilizing old clinical studies for a product which is already on market for the last 15 years?
  • Članak 10. MDR-a

    Zahvaljujem na zanimljivom predavanju. Ako nije problem, zanima me tumačim li dobro Članak 10. MDR-a kad je u pitanju QMS i IMD. Razumijem li dobro da proizvođač ispitivanog MD, koji tek razvija svoj prvi proizvod i nema zaposlenike već samo otvorenu firmu s upravom, nije dužan uspostaviti QMS dok proizvod nije u fazi pripreme za certifikaciju? Jasno mi je da sustav ne može funkcionirati bez zaposlenika, no on se ipak može smatrati proizvođačem IMD-a iako ima podugovorenu proizvodnju istog kod certificiranog proizvođača. Da li dobro tumačim? Puno hvala i lijep pozdrav,
  • Quality Control Documentation

    Can you please help me how to start to learn about Quality Control Documentation?

  • ISO 14001 communication procedure lacking in ISO 13485

    In the iso 14001 EMS there is a section about communication within the company. However in the iso 13485  toolkit there is no such procedure or document. Why is this?. We have our audit on Monday, and one point within iso 13485 is about communication. How should I think here?
  • Enquiries on Project Plan and review

    I have started to implement the SOPs and Appendices provided to me previously and requires clarification on one of the appendices, Project Plan and review. May I know what do I have to fill in under the column for "inputs", "deliverables" and "resources"? Do you have some example to show us what kind of information do we have to fill in?
  • Amount of staff ISO 13485

    We have seen a reduction in staff in company due to reduction in sales and we are wondering how that can affect our ability to hold and maintain iso 13485. Are there any fixed numbers of staff that one must have to obtain iso 13485 and if staff continues to reduce, what actions should we take. For instance we have our iso certification next week and if we are approved for the iso13485, what can happen afterwards if lets say people decide to leave the company? We are a total of 5 personell today, what would happen if we are only 2 or 3? Should this be risk assessed?
  • Info packaging

    We import medical devices to *** from ***. *** product was CE certified under MDD and can be placed on the market under MDR. The question is how much the product is covered by regulations concerning information provided with the product (section 23 of appendix to MDR)?
  • Translation of IFU

    In order to have your instructions for use translated you have to ensure that the translation is correct a professional. We have a class III product only used by HCP's. We use a certified translation company who dispatches translation certificates (translated by native speaker with knowledge of the specific discpine and reviewed by a second reviewer). Is it correct that after the IFU has been translated an additional validation needs to be done of the translation by a subject matter expert (HCP) for each language?
  • Mandatory documents for SaMD to develop QMS

    I have a question for you, and want to ask for your opinion. We are an  AI software team in a *** hospital. Our product is similar to ***. Our pneumothorax algorithm could automatically identifies findings suggestive of Pneumothorax based on chest X-ray scans and outputs an alert. Because this product is a pure software, i.e. SaMD(Software and medical device), we do not manufacture physical medical equipment and don't have some activities. For example, there is no sterilization activity in our production processes. I would like to know what documents are mandatory for a SaMD to develop a QMS? Looking forward to hearing from you
  • Ang release of Product

    Which document in the ISO 13485 toolkit dictate release of product and who is responsible for releaseing? Cant seem to find it
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