Doing or planning to do business outside of the US? Visit our sister companies. RQMIS AR LTD. or RQMIS EU SL More

About Us

Our mission is simple: Get our clients' products to market, and keep them there.

Since 1996, RQMIS has been providing companies with strategic guidance on how to effectively navigate regulations all around the globe. We currently have company locations in the US, Spain and the UK.

RQMIS stands for "Regulatory/Quality Management Information Source". Our team of consultants is led by a former FDA reviewer from the Office of Device Evaluation, Boston district. Our regulatory consultancy focuses on four principle areas: Regulatory Strategy and Submissions, Clinical Study Design and Management, Quality Systems Design and Compliance, and Insurance Reimbursement.


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We operate as a family business, meaning our clients are always our first priority. We understand the frustration and confusion that comes with navigating the regulatory "red tape" which is why we're always available to our clients. We're not too busy to answer a phone call, an email, or make an in-person visit. RQMIS is in this with you, and at the end of the day we want to see you and your product succeed.

Our goal is always the same - to execute the most efficient and cost-effective commercialization pathway for our clients worldwide. We like to say we're a "one-stop-shop", offering not just Regulatory solutions but Quality and Clinical as well. Rather than educating our consultants on a wide range of specialties we prefer to work with a larger team where each person has their niche that they are expertly trained in. This means you're always getting 110% when you work with us.

We're proud to boast of a team from a wide range of backgrounds including SaMD, AI, cardiology, ortho and pharma, all the way to veterinary and environmental fields.


Want to be treated as more than just dollar signs? Join the RQMIS family.


RQMIS Expertise By Market Segment

All Device Classes - I-III, Active Implantables and Human Tissue

Gastroenterology/Urology/Pulmonology/Plastic Surgery/Cardiology

  • Hemodialysis Systems
  • Radiofrequency and Irreversible Electroporation
  • Endoscopy/Laparoscopy/Bronchoscopy and Accessories
  • Minimally Invasive Surgical Instruments/Implants
  • Biliary Stents
  • Ultrasonic Imaging
  • Ostomy Devices/Accessories

Oral/Maxillofacial/Dental

  • Dental Implants
  • TMJ Implants
  • Bone Filling/Augmentation Materials
  • Dental Restorative Materials
  • Orthodontics

Combination Products

  • Advance Therapy Medicinal Products (ATMP)
  • Drug/Device/Biologic Combination

IVD

  • Clinical laboratory testing
  • Near-patient testing
  • Self-testing

RQMIS Expertise By Business Support Services

Business Management

  • Overall integration of Regulatory/Clinical/Quality Processes/Function into business processes
  • Acquisition Due Diligence – Regulatory/Clinical/Quality Focus
  • Product Management of Spinal Implants

Regulatory - United States

  • FDA Negotiations
  • Premarket Notifications (510(k)) – Including Notes to File
  • Investigational Device Exemptions (IDE) and Supplements
  • Premarket Approval Applications (PMA) and Supplements
  • Labeling/Promotional Materials Review
  • Registration and Listing

Regulatory - Rest of World

  • Premarket Submissions

Quality

  • ISO 13485 Quality System Design/Compliance/Auditing
  • FDA QSR and Human Tissue GMP Design/Compliance/Auditing
  • FDA Negotiations/Responses to 483’s, Warning Letters and Recalls

Clinical

  • Overall Clinical Study Management – phase II, III and Post Marketing Surveillance
  • Study setup and CA/IRB/EC submissions
  • Protocol Management in the US, EU, Israel, Brazil, Turkey, and South Africa
  • Clinical Affairs Process Development and Procedures
  • Study Monitoring
  • Developed/Managed Data Safety Monitoring Boards
  • Clinical Report Writing
  • Protocol design/development
  • Case Report Form design/development
  • Insurance Reimbursement
  • Bioresearch Monitoring

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