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Medical Device Consulting Ô°ÇøÒùÂÒ

When It Needs to Be Done Right, Manufacturers Trust NAMSA

From biological safety plans to FDA strategy and support, Ô°ÇøÒùÂÒhas deep expertise in medical device compliance. Our team of 100+ QA/RA and biological safety consultants, medical writers, scientists and market research experts all have first-hand experience with industry manufacturers. They understand how to balance the benefit-risk ratio with the practicalities of regulatory compliance. Because Ô°ÇøÒùÂÒperforms preclinical studies, clinical research and testing on thousands of medical devices and IVDs each year, our consultants come to each project with a well-informed sense of what the US FDA, European Notified Bodies and other regulators expect to see.

We Can Assist You in the Following Areas

US FDA Consulting

Regulatory pathways, PMA, 510(k), DeNovo, IDE, Pre-Sub meetings

EU MDR/IVDR Consulting

Strategy, CER/CEP, PER/PEP, PMCF/PMPF, technical documentation

Biological Safety Consulting

Biological evaluation plans and reports, toxicology risk assessments

Market Research

Go-to-market strategy, pricing and competitor research, customer insights

Global Consulting

QMS audits, ISO 14971, postmarket surveillance, combination products

100% Focused on Medical Devices and IVDs

200+

EU Clinical Evaluation Plans and Reports Prepared Each Year

100+

US FDA Pre-Submission Meetings Managed Each Year

800+

Medical Device Biological Safety Plans and Reports Prepared Last Year

1,700+

Medical Device Market Research Projects Completed

Meet NAMSA’s Team of Experts

Explore the depth of our team’s expertise in biological safety, EU MDR/IVDR, FDA compliance, market research, and more.

Meet All of Our Consultants
  • Adam Saltman, PhD, MD

    Principal Strategy Consultant, Clinical and Regulatory Ô°ÇøÒùÂÒ
    View Bio
  • Don Pohl, BS

    Principal Strategy Consultant, Biocompatibility
    View Bio
  • Chris Mullin, MS

    Chris Mullin
    Director, Global Strategy Ô°ÇøÒùÂÒ
    View Bio
  • Pedro Eerdmans, MD, PhD

    Director, Global Strategy Ô°ÇøÒùÂÒ
    View Bio
  • Jane Arnold-Round, MSc

    Senior Principal Consultant, Regulatory
    View Bio
  • Carla M. Wiese, BS-Mech Eng

    Carla Wiese
    Principal Strategy Consultant, Regulatory
    View Bio

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