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    ISO-13485-blog

    All posts by: Kristina Zvonar Brkic

    What are the post-market surveillance requirements in the MDR?
    For each medical device that is to be sold in the European Union market, the manufacturer must prepare the technical...
    For each medical device that is to be sold in the European Union market, the manufacturer must prepare the technical documentation to demonstrate that the device was designed and manufactured in accordance with all applicable...
    How to classify medical devices according to the EU MDR
    With the new Medical Device Regulation, it is important for medical device manufacturers to understand how the new classification rules...
    With the new Medical Device Regulation, it is important for medical device manufacturers to understand how the new classification rules apply to the different types of medical devices. These new EU MDR classification rules can...
    How to write clinical evaluation reports under the EU MDR
    No matter what medical device you make, if you wish to sell within the European Economic Area, you will need...
    No matter what medical device you make, if you wish to sell within the European Economic Area, you will need to meet the requirements of the Medical Device Regulation (MDR), and in particular the requirements...
    Comparison of the EU MDR and IVDR regulations
    With the new EU Medical Device Regulation, many companies need to ensure that they are in compliance with this new...
    With the new EU Medical Device Regulation, many companies need to ensure that they are in compliance with this new regulation in order to be able to sell medical devices in the European Union. This...
    How to write a good ISO 13485 Quality Policy
    When implementing a Quality Management System (QMS) for your medical device manufacturing organization, you will find that one of the...
    When implementing a Quality Management System (QMS) for your medical device manufacturing organization, you will find that one of the first things you need to write according to ISO 13485:2016 is your Quality Policy. So,...
    What are the EU MDR technical documentation structure and requirements?
    The main purpose of technical documentation in the EU Medical Device Regulation (MDR) is to prove that a medical device...
    The main purpose of technical documentation in the EU Medical Device Regulation (MDR) is to prove that a medical device meets the general safety and performance requirements. Regardless of the class, technical documentation is mandatory...