- Hemodialysis Systems
- Radiofrequency and Irreversible Electroporation
- Endoscopy/Laparoscopy/Bronchoscopy and Accessories
- Minimally Invasive Surgical Instruments/Implants
- Biliary Stents
- Ultrasonic Imaging
- Ostomy Devices/Accessories
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 the medical device, pharma, nutraceutical and cosmetics regulations all around the globe. RQMIS currently have company locations in Boston (US), Barcelona (EU) and in London (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.
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 are proud to have a team from a wide range of backgrounds including SaMD, AI, cardiology, orthopedics, pharmacy, cosmetics and nutrition to the veterinary and environmental fields.
If you are an expert consultant join the RQMIS family!