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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
EU Clinical Evaluation Plans and Reports Prepared Each Year
US FDA Pre-Submission Meetings Managed Each Year
Medical Device Biological Safety Plans and Reports Prepared Last Year
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.
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Adam Saltman, PhD, MD
Principal Strategy Consultant, Clinical and Regulatory Ô°ÇøÒùÂÒView Bio -
Don Pohl, BS
Principal Strategy Consultant, BiocompatibilityView Bio -
Chris Mullin, MS
Director, Global Strategy Ô°ÇøÒùÂÒView Bio -
Pedro Eerdmans, MD, PhD
Director, Global Strategy Ô°ÇøÒùÂÒView Bio -
Jane Arnold-Round, MSc
Senior Principal Consultant, RegulatoryView Bio -
Carla M. Wiese, BS-Mech Eng
Principal Strategy Consultant, RegulatoryView Bio