Post-Market Clinical Evidence for Medical Devices

PMPF Gap Assessment and Strategy

Under the EU In Vitro Diagnostic Regulation (IVDR 2017/746), Post-Market Performance Follow-up (PMPF) is a mandatory, ongoing process for all IVD manufacturers with CE Marking. It plays a vital role in Post-Market Surveillance (PMS) by continuously collecting and evaluating real-world performance data to confirm the device’s safety, scientific validity, and clinical effectiveness throughout its lifecycle. Required under Annex XIII, Part B, PMPF applies to all IVD devices regardless of classification and feeds into the Performance Evaluation Report (PER), helping identify emerging risks and demonstrate continued compliance to Notified Bodies.

Post-Market Clinical Investigations

NAMSA offers comprehensive expertise in post-market observational studies for medical devices, supporting everything from protocol development to final reporting or publication. Led by seasoned professionals—including former FDA and EU regulatory reviewers—the team provides tailored services such as post-market monitoring, post-approval studies, and EU-compliant PMCF. Their global infrastructure supports studies of all sizes, with capabilities in site and data management, EDC systems, project oversight, regulatory submissions, and medical writing. NAMSA also leverages real-world clinical data and biostatistical expertise to enhance study outcomes and ensure regulatory compliance. By outsourcing to NAMSA, companies can streamline operations, reduce costs, and accelerate timelines while maintaining high-quality, globally compliant results.

High-Quality Clinical Surveys and Questionnaires

Under the EU MDR and IVDR, PMCF surveys are a vital tool for collecting real-world clinical data from healthcare professionals and patients to validate device safety and performance throughout its lifecycle. NAMSA offers an end-to-end PMCF survey service—from strategic planning and protocol development to survey design, participant recruitment, data analysis, and regulatory reporting—tailored to your device’s risk profile and regulatory needs. Whether conducting low-complexity perception surveys or high-quality, patient-level data collection, NAMSA ensures compliance, data integrity, and actionable insights. With a multilingual team, global reach, and deep regulatory expertise, NAMSA helps MedTech companies meet Notified Body expectations and build robust clinical evidence efficiently and effectively.

Literature Reviews

Our thorough literature reviews analyze existing research to support your claims, providing a solid foundation for regulatory submissions. They are also often used to develop performance goals for single-armed pivotal studies.

Clinical Trial Rescue Studies

When clinical trials falter, sponsors face mounting pressure from delays, budget overruns, and regulatory risks. NAMSA specializes in clinical trial rescue, stepping in with strategic leadership, deep clinical insight, and hands-on site engagement to restore momentum. Through tailored diagnostics, gap analysis, and proactive communication, NAMSA rebuilds trust, accelerates enrollment, and drives studies toward successful completion—earning repeat partnerships from sponsors who value results when it matters most.

Clinical Outsourcing

NAMSA is the leading clinical outsourcing partner trusted by medical device and IVD manufacturers because we focus exclusively on devices. With deep regulatory expertise, ISO 14155 compliance, and a full suite of services—from clinical trial management to biostatistics and medical writing—we help clients accelerate timelines, reduce risk, and achieve regulatory success. Whether you need flexible staff augmentation or full-service trial support, NAMSA delivers unmatched device-specific knowledge and results.