Comprehensive Regulatory Lifecycle Support – MDD Maintenance, MDR Transition & PMS Strategy for Interventional Devices

Project Summary

Celegence partnered with a leading medical device manufacturer known for its extensive portfolio of interventional and implantable medical devices, including catheters, stents, introducers, drainage systems, and embolization products. These are primarily used in vascular access, peripheral intervention, urology, and gastrointestinal procedures. The engagement included support across the full regulatory lifecycle—ranging from MDD annual maintenance and MDD-to-MDR conversion to the development of new MDR-compliant CEPs, CERs, PMCF plans, and PMS reports. Celegence also leveraged specialized software to efficiently manage large volumes of documentation across a broad portfolio of products.

Celegence Solution & Approach:

Celegence delivered scalable support across multiple product families by:

Highlights:

Running multiple concurrent projects for both legacy and novel devices under MDD and MDR frameworks

Authoring high-quality MDR CEPs/CERs across several product types with varying levels of clinical evidence

Conducting comprehensive SOTA reviews and mapping measurable safety and performance endpoints

Executing in-depth risk mapping to identify new or emerging risks, prompting updates to risk files and IFUs

Establishing acceptance criteria by identifying data from similar and alternative devices

Designing targeted, cost-effective PMCF activities to fill clinical data gaps

Utilizing regulatory software solutions to streamline document development and evidence management