From IVD regulatory consulting to clinical and post-market support, we’ve got what you need, when you need it. 

NAMSA can work with your team in several capacities on a global scale. Some clients choose to outsource their full product development program, while others partner with us on portions of a regulatory or clinical process. No matter the program, NAMSA is the most flexible IVD CRO partner in the industry, and we pride ourselves on delivering only high-quality results by leveraging our collective expertise. 

On a daily basis, NAMSA partners with global regulatory bodies to understand expectations and new regulations. We know how to navigate regulatory requirements throughout every territory in the world. 

It’s a full-time job keeping up with regulations within each global market and therapeutic areas that pertain to your business. NAMSA has a local presence in every key medical device territory around the world to support specific regulatory strategy requirements and long-term goals.

We realize that IVD clinical trials are vastly different from medical device and pharmaceutical trials. We have a broad network of trusted patient sites with whom we’ve worked in the past, and are continually focused on building relationships with new sites, all to serve your clinical trial needs better.

IVDs: The product development lifecycle is different, the site requirements are different, data collection varies and there are unique challenges that manufacturers must mitigate. NAMSA works with clients every day to overcome these challenges, and applies lessons learned to help you accelerate your product through the clinical trial phase.

 NAMSA is flexible and can work with you for all regulatory consulting, quality system and clinical research needs, a la carte or as a turnkey solution. 

Services Provided by NAMSA:

Regulatory and Medical Writing

  • Global Strategy & Submission
  • 510(k)
  • CE Mark
  • Submissions
    • China FDA
    • Health Canada
    • EU
    • PMDA
    • FDA
  • Submissions for Companion Diagnostics
  • Premarket Approval (PMA)
  • Investigational Device Exemption (IDE)
  • Device Master File
  • Design Dossier / Technical File
  • In Vitro Diagnostic Regulations (IVDR)
  • Performance Evaluation Report Creation and Updates (PER)

Clinical Research, Biostatistics and Data Management

  • Study Types: Feasibility, Pivotal, Specimen Collection, Human Factors, Reproducibility, Limit of Detection, Clinical Performance, Formative & Summative Usability
  • Postmarket Surveillance (PMS)
  • Study Design & Implementation
  • Site Selection/Qualification
  • Biostatistics/Data Analysis
  • Database/Data Management
  • Clinical Audits and Bioresearch Monitoring (BIMO) Audit Support
  • Instructions for Use 

Quality Systems

  • Development Support
  • Gap Analysis
  • ISO 13485:2016 Transition
  • Quality Audits 

Are NAMSA’s services a good fit for your needs? Contact a NAMSA representative +1-866-666-9455 (+1-419-666-9455 outside the U.S.) or via our contact form.