Three Key Stages -
Three Common Pitfalls

As the medical device industry has reached the May 2021 MDR implementation deadline, RQM+ has released a concise whitepaper outlining three major pitfalls which medtech companies are often falling into, as well as best practices to avoid these common hurdles.

Planning strategy based on these best practices will help companies develop a strong rationale for PMCF activities that can be clearly presented to a notified body.

The MDR significantly raises the bar for the quantity and quality of clinical data required for PMCF. Since this is a new level of clinical evaluation, many businesses are experiencing similar challenges.

As the deadline for compliance has arrived, it is critical that medical device companies do not fall behind in their compliance activities, as they continue to face ongoing pressures. The positive message of this paper is that in these demanding circumstances, good planning will deliver optimal results in PMCF compliance.


  • Our work with clients has revealed a number of common pitfalls that
    have emerged, each of which could have significant commercial
    consequences if not addressed
  • This short paper aims to highlight common pitfalls, alongside a
    reminder of the three main best practice steps to compliance, to help
    manufacturers optimize their competitive positioning

To access the “PMCF Under MDR Whitepaper” please fill out the form on the page.

Fill out the form to receive your PMCF Under MDR Whitepaper.

“Together you all moved the mountain. I am greatly appreciative and humbled by all of your commitment to excellence. Thank you for all you have done for [our company].”

MDR submissions senior manager

Large multinational medical device manufacturer