Regemon LLC
  Regulatory Affairs and Quality Systems Consulting
Regulatory Compliance

Regemon consultants provide practical solutions and work with you to develop and implement effective regulatory strategies, prepare domestic and international regulatory submissions, manage FDA and foreign regulatory agencies (EU Notified Bodies, SCC, MHLW, SFDA, etc) inspections and train your employees in all aspects of regulatory compliance.


Product Compliance

§         FDA Premarket submissions: 510(k)1, PMA and IDE

§         International submissions:CE Design Dossiers, CE Technical Files, Health Canada class II, III and IV Submission Files, STED

§         Device classification/ Predicate Devices Search

§         Product Modifications strategies

§         EU Clinical Risk Benefits Summary Reports


Post-Market Compliance

§         Product-specific compliance strategies

§         Complaint Handling- Evaluation, investigation and documentation

§         Preparation of FDA Adverse Event Reports (MDR)

§         Preparation and submission of EU Vigilance Reports


Resolving Regulatory Problems (Crisis Management)

§         FDA Enforcement Action resolution

§         Warning Letter remediation services

§         FDA Inspection: prepare a successful 483 response

§         Global Product Recalls incl. communication with FDA and international regulatory agencies

§         Responding to questions from FDA


1) Submissions Strategy for a small medical device company

A small company ready to enter the medical device arena has no current experience gaining clearance with the FDA.  Regemon explains the regulatory process, advises on the documents needed, prepares and successfully submits the 510(k).

Welcome Regulatory Compliance Quality Systems Training EU (CE-Marking) Compliance Resources Contact Us

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