Our vision is simple: To be the provider of choice for the development and implementation of regulatory and insurance strategy by utilizing the most efficient and effective commercialization pathway to medical product markets across the globe, including designing the quality system that brings the product to life. When these pathways demand clinical evidence to validate that a product is safe and effective, whether it is for publication, insurance reimbursement or regulatory approval, RQMIS provides our customers with complete support for the entire product lifecycle.Since 1996, RQMIS has been providing manufacturers in the medical and healthcare industries with strategic guidance on how to effectively navigate the FDA and EU regulations. Our consultancy is focused primarily in four areas: Regulatory Strategy and Submissions, Clinical Study Design and Management, Quality Systems Design and Compliance, and Insurance Reimbursement. Our headquarters is located in Boston, MA and we have two additional locations in London and Barcelona.

Medical Devices Regulatory Clinical Consulting Quality Management Systems 510(k) FDA Clearance EU MDR / IVDR Clinical Trial Design EU Authorized Representative US Agent Audits FDA Presubmission Techincal Files Clinical Evaluation Report (CER) Regulatory Strategy Product Classification Insurance Reimbursement Medical Equipment Management Services Management Consulting