• The importance of good Design process and documentation.

    If you wonder how important your good Design process and documentation should be ? 

    I coverred following news for you

  • ISO 13485

    ISO 13485 New Edition

    ISO 13485 vers. 2016 has been published and a 3-year transition period is currently ongoing.

    Even if you have a good working QMS running, some basic GAPS needs to be tackled.

  • European flag

    New MDR

    The draft MDR is already available and you can download it here (with index)