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Device Consulting Services

Dedicated experts with decades of hands-on experience with devices are at your service every step of the way.

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 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