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RQMIS

Integrating Regulatory, Clinical and Quality requirements with lifecycle success

Trust RQMIS with designing and implementing the regulatory, clinical and quality systems strategy to support your medical device, nutraceutical, cosmetic, medicine idea. We know what it takes to get your idea to market and keep it there.

Explore our regulatory, quality, and clinical services for your medical device, drug, nutraceutical, or cosmetic product

Just getting started with a medical device? Start down your path to market

RQMIS provides therapeutically focused comprehensive regulatory, quality and clinical consulting to the global medical device, pharmaceutical, nutraceutical and cosmetic industries.

The regulatory, quality and clinical consultancy is focused in three principle areas:

Regulatory Strategy and Submissions

Clinical Study Design and Management

Quality Systems Design and Compliance

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510(k) FDA Submission Repair

  • Worked with the FDA to understand issues with an existing submission
  • Clarified and repaired the submission per FDA feedback
  • Recommended a lower-cost solution to the request for a clinical study

EN/ISO Recertification Audits

  • Pending Notified Body (NB) audit
  • Conducted an internal audit in anticipation of the NB audit
  • Passed NB audit with additional positive feedback

TMF Clinical Trial Study Rescue

  • Re-established communication with the FDA
  • Hired and created a clinical team
  • Fixed a broken, neglected study

FDA Inspection of a Combination Product Manufacturing Facility

  • Manufacturer in the EU faces their first combination-product facility inspection
  • Conducted a gap analysis and updated the manufacturer's quality system
  • The inspection found only four minor observations

Regulatory Pathway for a Novel Technology

  • Novel technology with no predicate device
  • Negotiated a pathway with the FDA

Regulatory Strategy for FDA Warning Letter

  • FDA Warning based on an inspection
  • Created a corrective and preventive action plan in just two weeks
  • Negotiated continued product sales