Monitoring services for multi-center device study in Denmark

Post-market Clinical Investigation:

For post-market clinical investigations, the principles set forth in ISO14155:2020 document are intended to be followed as far as relevant, considering the nature of the clinical investigation.  According to the standard a post-market clinical investigation is carried out following market approval of a medical device, and is intended to answer specific questions relating to clinical performance, effectiveness or safety of a medical device when used in accordance with its approved labelling. Several points of the standard compared to pre-market studies can be avoided under post-market settings that can make these investigations administrative more simple.

Qmed can help you:

  • Set up a post market clinical follow-up (PMCF) plan including the use of registers and surveys
  • Write up the applicable clinical documents needed
  • Assure the needed approvals if applicable
We act as you full-service CRA.
Be aware that if marketed products are being investigated for new indications, other than described in the approved labelling, normative directions for pre-market clinical investigations apply.