Latest articles:

  • ISO 13485 procedures and SOP template for medical device quality management system documentation

    Best Tips: ISO 13485 procedures with our free template (Version 2016)

    Have you ever been in this situation where you have to create the ISO 13485 procedures (or [...]

    by Monir El Azzouzi

  • Medical device registration in Saudi Arabia with digital approval, checklist, and compliance icons

    How to Register Your Medical Device in Saudi Arabia?

    Are you looking for a new market opportunity for your medical device? Do you want to expand [...]

    by Monir El Azzouzi

  • Digital illustration of medical device Quality and Regulatory Affairs tools including QMS dashboards, eIFU management, labeling, and risk compliance

    Best Quality and Regulatory Affairs Tools (Medical Devices)

    The UDI or “Unique Identification Number” Europe (as there is also one in the USA) is one of the new [...]

    by Monir El Azzouzi

  • Declaration of Conformity document for MDR and IVDR medical device with CE marking on clean surface

    How to write a Declaration of Conformity? (MDR and IVDR)

    The word “Declaration of Conformity” is written 38 times on the EU MDR 2017/745. This is, if I [...]

    by Monir El Azzouzi