Medical Device Clinical and Regulatory Strategy Roadmap Consulting

Gain a Clear View of What’s Ahead

When the path forward is unclear, clients worldwide come to us for advice. NAMSA helps medical device manufacturers develop a comprehensive plan to navigate the complex landscape of clinical and regulatory requirements that lead to market approval.
We offer a unique perspective because we are involved in every aspect of the regulatory approval life cycle including preclinical research, clinical trials, and device testing. This perspective differs from most consulting firms who can only speculate about the data that FDA or Notified Bodies will require based on their interpretation of published standards and guidance. We do not need to speculate because we produce the data and understand the reality of what regulators expect to see.

Our team of experts conducts a thorough analysis of your device, identifying optimal preclinical, clinical, and regulatory pathways. We assist in designing and implementing required preclinical testing, clinical trials, preparing regulatory submissions, and ensuring compliance with global standards.

Examples of Projects We Have Supported

Here are some examples of the projects we have recently completed for clients.

• An established European manufacturer was considering conducting a global pre-market clinical investigation for a novel and cardiovascular device in the US, EU, and Australia. We helped understand the regulatory pathway and timelines associated with initiating a clinical investigation in each market so they could determine which market to pursue first.
• A US start-up device manufacturer developed a wound care device that required 510(k) clearance. Although a clinical study was not required, the clinical data was valuable to the client. We assisted them in selecting the country for the study based on the criteria: regulatory requirements, ethical approval process, timeline, operational aspects, investigator commitment, and appropriate patient population.
• An established Japanese manufacturer wanted to bring their neurovascular devices to the US and the EU. We developed a detailed strategic summary including biocompatibility, preclinical, clinical, and regulatory requirements for bringing their devices to market in the US and EU.
• A South Korean manufacturer of dental implants wanted to introduce their products to the US market. We helped them understand the 510(k) submission process, identified the predicate devices, and supported the preparation of the necessary documentation, including biocompatibility and clinical data, to ensure a smooth regulatory pathway.

Support for US FDA, EU, and International Regulatory Submissions

NAMSA’s deep team of consultants in the US and Europe have experience with all facets of FDA and EU MDR/IVDR compliance, including strategy consulting, clinical trials, and documentation preparation in support of medical device regulatory submissions. Many members of our team have experience working for the US FDA, EU Notified Bodies, or other regulators. We can assist with planning and strategy for medium and high-risk device submissions including:

• EU MDR Class 2a, 2b and 3
• EU IVDR Class C and D
• FDA IDE and De Novo Submissions
• FDA PMA and 510(k) Submissions
• Japan PMDA, Health Canada, TGA, and more

From initial concept through post-market activities, we provide continuous support to address challenges and optimize your strategy. Partner with us to streamline your clinical and regulatory processes, reduce risks, and achieve successful product approvals.