Ximedica

Clinical & Regulatory

Clinical & Regulatory

Regulatory and Clinical Affairs at Ximedica provides the knowledge, insight and capabilities to guide development through the maze of medical product regulations around the globe.

Regulatory experts from day one

From the very first kick-off meeting our regulatory experts work with development teams to mitigate risk without hindering innovation. Their task is to uphold the highest safety standards while ensuring an expedient path to approval.

Regulatory experts who have deep knowledge of the FDA and hands-on experience in medical

Our team is deeply experienced at interpreting regulatory schemes, agencies, rules, standards and procedures and developing strategies that enable development teams to operate and reach their goal in an efficient manner. Prior “hands on” experience as practicing clinicians, researchers and product developers makes us ideal partners in executing pre-clinical, animal, simulated use and actual use research and product testing projects.

From early strategy to final submission we assist with all

Our team serves as the Official Correspondent for FDA submissions, and the U.S agent and sponsor for companies located outside the US.

Our activities include:

  • Regulatory intelligence and market analysis
  • Global regulatory strategy
  • Pre-IDE/IND FDA meetings and applications
  • 510(k), PMA, and NDA submissions
  • CE Mark TF/STED/Dossier
  • Import/export certification
  • Institutional Review Board governed studies
  • Notified body interactions with the EU
  • Technical file and design dossier preparation
  • Integration of clinical assessments with regulatory strategy

 

Related Resources

Wherever you are in your process, Ximedica can help.

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At Ximedica, our people define who we are.

More About Our People

Brian Lewis

Brian Lewis

Director of Program Management

Dan Nelson

Dan Nelson

Electrical Engineer

Kate Pereira

Kate Pereira

Director, Program Management

Joe Gordon

Joe Gordon

Director of Innovation

Dick Rubin

Dick Rubin

Vice President of Sales & Marketing

Maria Swenson

Maria Swenson

Senior Design Assurance Engineer