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RQMIS

Driving Lifecycle Success Through Seamless Regulatory, Clinical, and Quality Integration

Transform your innovative ideas into market-ready solutions with RQMIS. Our expert team specializes in crafting seamless regulatory, clinical, and quality strategies that not only bring your medical device, nutraceutical, cosmetic, or pharmaceutical product to market but ensure it thrives there.

Unlock Your Product's Path to Market Success – Discover Our Expert Regulatory, Clinical, and Quality Solutions Today!

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Take the First Step Toward Market Success with Confidence!

At RQMIS, we specialize in designing and implementing comprehensive regulatory, clinical, cybersecurity, and quality systems strategies tailored to bring your medical device, cosmetic, nutraceutical, or pharmaceutical idea to life in the global market.

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