Tag Archives: regulations

Qserve Conference 2016 Hot Regulatory TOPICS in the MEDICAL DEVICE sector

On the 4th and 5th of April J-Link participated in the Qserve Conference 2016 on regulatory topics in the medical device sector.  During this conference inspiring speakers from the medical device industry and healthcare authorities from all over the world spoke on the topics below.

During the conference a broad range of major topics within the medical device industry were discussed, thinking of subjects as: The new medical device regulations (MDR), smartphone applications as medical devices, the new ISO 13485 and how to implement this knowledge.


  • Industry perspective on Medical Device Regulation (MDR).
  • The EU Medical Device Regulation challenges – strategies to implement the regulation.
  • Invitro DR.
  • Notified Body approach to the new MDR.
  • Regulatory requirements for (medical) software applications.
  • ISO 13485 : 2016.
  • Implementation of ISO 13485 : 2016.
  • International perspective on new clinical evaluation regulations.
  • Notified Body view on clinical evaluations.
  • Strategic approach to PMCF.