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Device Consulting Services

Dedicated medical device experts with decades of hands-on experience with devices are at your service every step of the way. Our medical device consultants can offer support on device design, regulatory solutions, and breakthrough device designation. From 510(k) support, to regulatory and strategy consulting, we will help you navigate through any medical device challenge.

Medical Device Regulatory Strategy & Due Diligence

  • Provide short and long term regulatory strategy for medical devices, IVDs, and combination products
  • Serve as expert witnesses for litigation matters related to medical device regulation and technologies
  • Conduct due diligence assessments

FDA Meeting Preparation & Engagement

  • Represent clients in interactions with FDA
  • Assist clients in preparing for FDA meetings and FDA Advisory Panel meetings

FDA Submissions

  • Prepare or assist in the preparation of regulatory submissions for medical devices, including 510(k)s, PMAs, IDEs, de novos, Pre-Submissions, HDEs, 513gs and RFDs
  • Assist clients with development of bench, animal and clinical testing protocols and interpreting results
  • Provide clients with a comprehensive “FDA style” review of submissions
  • Assist with responding to FDA deficiency letters

Combination Products

  • Provide insight, strategy, and guidance on combination product development, including novel drug delivery systems

In Vitro & Companion Diagnostics

  • Expert technical guidance on In Vitro Diagnostic product development and regulatory strategy, including companion diagnostics and personalized medicine products
  • Analytical and clinical study design and study management

Quality Systems & Training

  • Assist with Quality System documentation development including expert technical reviews of software development procedures
  • Perform mock audits
  • Provide in-house training on FDA regulatory issues and new policy developments