Premarket Clinical Evidence for Medical Devices
Expertise in Premarket Evidence Generation
NAMSA understands the critical importance of establishing robust premarket clinical evidence for successfully achieving marketing authorization, reimbursement coverage, and clinical adoption. Our medical device evidence generation expertise is built to support these outcomes through tailored solutions that meet regulatory and payor requirements while earning the confidence of patients and healthcare professionals alike. With our comprehensive, end-to-end approach, you’ll benefit from direct access to a global network of regulatory, Key Opinion Leader (KOL), and clinical research experts. These integrated evidence generation consulting services help evaluate your options and execute the optimal strategy so you can navigate the path to commercial success efficiently and effectively.
Services to Support Clinical Evidence Generation
At NAMSA, we offer a variety of additional services to enhance your clinical evidence generation process:
- IDE Applications and Submission: We assist in preparing and submitting Investigational Device Exemption (IDE) applications to ensure compliance with FDA requirements and maximize the likelihood of a quick approval.
- FDA Presubmission Meeting Support: Our experts help you prepare for and navigate FDA presubmission meetings by designing thoughtful and impactful questions for FDA and packaging the right submission information to get the most value out of the presubmission interaction.
- Statistical Analysis Plan: We develop comprehensive statistical analysis plans to guide the evaluation of your clinical data and ensure robust and reliable results. This includes clear hypothesis statements and mathematically sound sample size calculations. Our expert team of biostatisticians is well versed in advanced, alternative statistical trial methods such as adaptive designs and composite endpoints.
- Clinical Trial Synopsis and Protocol Design and Writing: Our team designs and writes detailed clinical trial synopses and protocols to ensure your studies are scientifically sound and meet regulatory standards.
- Informational Meeting Support: We help companies that have novel products explain their technology to FDA review teams, so that subsequent presubmission interactions and marketing applications move more quickly and smoothly.
At NAMSA, we are committed to guiding you through every step of the premarket clinical evidence generation process. Our team of experts is here to help you navigate regulatory requirements, design effective studies, and achieve successful device approval. Partner with us to ensure your medical device is ready to make a positive impact on patient care.
Early Feasibility/First-in-Human Studies
These initial first-in studies help evaluate a medical device’s safety and functionality for the first time in humans, providing critical insights for further product development.
Pivotal Studies
Larger, definitive trials using final product versions that provide comprehensive evidence of safety and effectiveness, commonly constructed as randomized controlled trials (RCTs) against other marketed devices or single-armed studies using accepted performance goals.
Human Factors and Usability Testing
We can design and execute small, formative usability studies that your team can use to advance product development as well as larger, summative studies on final product designs to support marketing applications. This testing helps optimize user experience and minimize risks.
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.
Frequently Asked Questions
Yes. Real-world evidence (RWE) is a recognized form of clinical evidence that the FDA can consider in a premarket medical device submission. The agency has made clear that RWE, derived from real-world data collected during routine use, can support regulatory decisions when it meets quality and relevance expectations. This means RWE can complement traditional clinical data, helping demonstrate benefits and risks in the context of actual patient care, not just controlled clinical trials.
NAMSA brings extensive, hands-on experience to FDA Pre-Submissions, supporting hundreds of Q-Sub and Pre-Submission meetings across device types and regulatory pathways. This volume of direct engagement gives sponsors practical insight into FDA expectations and common areas of regulatory risk. NAMSA’s team works closely with sponsors to define clear questions and prepare for positive, productive interactions with the FDA.
NAMSA assesses whether a study requires an Investigational Device Exemption based on device risk, intended use, and the role the study will play in regulatory decision-making. An IDE is generally required for U.S. clinical studies involving significant risk devices that lack marketing authorization for the indication being studied, including approved devices being evaluated for a new use. NAMSA evaluates study design, the regulatory status of the device, and the potential risk to human subjects to determine whether an IDE is necessary or whether an alternate regulatory approach may be appropriate under FDA requirements.
Why Companies Choose NAMSA
Medical Device or IVD Clinical Projects Each Year
Clinical Professionals on Staff
Medical Device Clinical Trials Supported
Therapeutic Areas in Which NAMSA Has Experience
Thanks to NAMSA, we were able to conduct the clinical investigation of our software as a medical device in full compliance with MDR and according to the highest quality standards.
Javier Fernández, Founder at PragmatechMeet Our Clinical Experts
Explore the depth of our team’s expertise.
-
Adam E. Saltman, MD, PhD
Chief Medical OfficerView Bio -
Corie Diaz, BA, MBA
Global Director, Clinical OperationsView Bio -
Dan A. Whitter
Associate Director, Clinical OperationsView Bio -
Wendy Schroeder, BSN, CCRC/PM, CRCP
Principal Strategy Consultant, ClinicalView Bio -
Chris Mullin, MS
Director, Global Strategy ServicesView Bio
Related Services That May Interest You
Medical Writing
Post-Market Clinical Evidence
