RQM+, the regulatory and quality consulting firm for medical devices and diagnostics, has released a new white paper to help manufacturers maintain momentum in their compliance activities, as they continue to face ongoing pressures.
Under EU regulations for medical devices (MDR), medical device manufacturers, including those in the access and mobility aids market, are seeing clinical data for their products undergo greater scrutiny.
Once their products have reached the EU market, manufacturers need to conduct Post-Market Clinical Follow-up (PMCF) investigations to collect additional information about their devices.
The new white paper, which focuses on these follow-ups, provides a planning strategy to keep businesses on track with their PMCF efforts, drawing attention to common pitfalls encountered by medtech companies.
The delay of the MDR deadline to May 2021 provided welcome relief to the industry, allowing businesses to focus on managing the impact of the pandemic.
However, RQM+ says is critical that medical device companies do not fall behind in their compliance activities.
Lisa Casavant, executive vice president at RQM+, said: “We’re aware that businesses may be under significant budgetary constraints in light of the pandemic, but this doesn’t mean that quality will have to be sacrificed. The key is to prioritize PMCF preparation efforts and get started as soon as possible.
“We hope that this paper will support these efforts, by providing some of the best practices, lessons learned, and collective knowledge from our regulatory, clinical, and former notified body experts who have supported our clients with MDR implementation over the last few years. At this critical juncture for MDR compliance, these lessons are invaluable in avoiding failed regulatory submissions and the resulting consequences.”