IM3 Consulting Group

   General Regulatory Services

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Our regulatory practice is not limited to just preparation of pre-market submissions, but includes all aspects of the regulatory “life cycle” for medical products, from design control to risk management to product improvements.  Our philosophy is to prepare submissions that are based on excellent science.  Because of this philosophy, we have a high level of credibility with FDA and other regulators, and members of our team are frequently asked to participate in FDA meetings.  

Our regulatory services include:

·     FDA Medical Device & Combination Device (Drug-Device or Biologics-Device) Submissions:  pre-RFD, IDE, IND, 513(g) – Device Classification, 510(k), PMA, NDA, HUD/HDE, & De Novo

·     Labeling Review

·     Risk Management (per ISO 14971)

·     Preparation of CE Mark Technical File or Design Dossier

·     Preparation of Clinical Evaluation Plan and Report according to MEDDEV 2.7/1 rev 4

·     FDA Meeting Requests

·     Responses to Submission or Deficiency Letters (either FDA or Notified Body)

·     Quality System Audits (per FDA 21 CFR 820 and/or ISO 13485)