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. That’s why we’ve developed tailored solutions designed to ensure your device meets 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 who can evaluate your options and execute the optimal strategy—helping you 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 small, initial studies help evaluate the 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.
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
Meet Our Clinical Experts
Explore the depth of our team’s expertise.
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Adam Saltman, PhD, MD
Chief Medical OfficerView Bio -
Corie Diaz, BA, MBA
Global Director, Clinical OperationsView Bio -
Dan A. Whitter
Associate Director, Clinical OperationsView Bio -
Deborah Mange
Sr. Manager, Clinical OperationsView Bio -
Wendy Schroeder, BSN, CCRC/PM, CRCP
Principal Strategy Consultant, ClinicalView Bio -
Chris Mullin, MS
Director, Global Strategy ServicesView Bio
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