Post-Market Clinical Evidence for Medical Devices

Expertise in Post-Market Evidence Generation

Medical device sponsors are acutely aware that regulatory approval is only one step on a long journey to create a meaningful business while supporting post-market safety and effectiveness monitoring. Post-market studies can also help expand regulatory authorization by providing clinical evidence to back new product claims and further reimbursement and market adoption objectives. It is also not unusual for regulators to require that new and novel devices be under observation for a period of follow-up after marketing authorization, as defined in the EU MDR and IVDR (i.e., the PMCF, PMS, and PMFP) or on condition of approval by FDA (522(g) studies, post-approval studies.) Post-market follow-up is also key to achieving compliance with Good Machine Learning Practices (GMLP) for artificial intelligence/machine learning medical devices.

Satisfying these requirements and business needs can present significant challenges for many sponsors. To help, NAMSA offers a broad array of clinical evidence generation and post-market study support services to assist sponsors in finding the right solution to meet their long-term needs.

Key Considerations for Developing Your Post-Market Clinical Evidence Strategy

When developing your post-market clinical evidence strategy, it’s crucial to define the purpose of your study. Whether it’s for FDA requirements, expanded marketing claims, or safety data, the purpose will drive the study design and dictate the level of rigor required to conduct the study. For example, business-driven studies that collect marketing, reimbursement, or clinical adoption data may require less rigor whereas regulatory-driven studies aimed at expanding claims or indications will demand greater rigor to ensure acceptable data quality. NAMSA stands ready to help design and execute all types of post-market studies, regardless of your specific needs and goals.

NAMSA Supports Numerous Types of Medical Device Post-Market Clinical Evidence

We support each client based on their unique post-market study objectives, carefully and thoughtfully taking into account desired timelines and budgets. Together with our global consulting team of regulatory and clinical experts, we can devise a study plan that meets your regulatory and business needs. Examples of our most requested study designs include:

• PMCF/PMPF Gap Assessment and Strategy
• Post-Market Clinical Investigations
• FDA Condition of Approval Studies
• Post-Market Patient Registry
• Literature-Based Meta-Analysis
• High-Quality Clinical Surveys and Questionnaires
• Vigilance Reporting
• Health Economics and Outcomes Research (HEOR)

At NAMSA, our approach to client engagement encompasses a wide range of services that meet the stringent requirements of regulatory bodies such as the FDA plus European Notified Bodies. With decades of experience, our team of experts is adept at designing and implementing post-market studies that provide valuable data, be it under controlled trial conditions or from real-world experience. We utilize advanced methodologies and technologies to collect, analyze, and report data, ensuring that you get the highest quality data you need quickly.

End-to-End Support for All Post-Market Studies

We meticulously select and qualify clinical sites, provide comprehensive training and support to site staff, and employ rigorous monitoring and auditing processes to ensure compliance with regulatory standards. By leveraging our extensive network of key opinion leaders and clinical sites, we ensure that only the highest quality data is collected to support regulatory submissions, market expansion, and reimbursement strategies. Our proactive approach to study risk management and quality assurance identifies and mitigates potential issues early, ensuring the smooth and successful execution of your post-market studies.

Partnering with NAMSA gives you access to a team dedicated to your success. We offer continuous support from initial study design to final reporting and any regulatory, reimbursement, and/or publication submissions, helping you navigate the complexities of post-market surveillance. Trust NAMSA to provide the expertise and support needed to generate the post-market clinical evidence required for your device’s ongoing success.