Rocky Mountain Regulatory and Quality Partners

medical devices

About

Welcome to Rocky Mountain Regulatory and Quality Partners, also called RMRQP. RMRQP specializes in Regulatory Affairs consulting and Quality System creation and remediation. We help our clients make sense out of Regulatory Affairs and Quality Systems, both domestically and internationally. Our consultants are well versed in domestic and international medical device regulations, the ISO certification processes, and working with government agencies in the U.S. and abroad. Consultants have extensive experience with MDD/MDR gap assessments and remediation, ISO 13485 auditing, EU CER (per MDR) auditing and creation (i.e. literature searches and reviews, CER authoring; clinical trial monitoring and reporting), 510(k) and PMA submissions, post-market surveillance, product and process validation, design engineering, and many others. Our staff of consultants brings real world experience to the table to develop solutions in a way that makes sense for the business. While many of us in the US think immediately of the FDA when regulations are mentioned, our global marketplace demands global compliance with a wide range of agencies and regulations. From the initial IDE through PMA, de novo pathway or 510(k), we can help take your concept through design. We create documentation necessary for CE Marking and other registrations around the world. RMRQP has built a group of professional quality and regulatory consultants capable of providing services for all elements of your medical device quality system. From the development of early regulatory and quality strategy, to creating and running a quality management system (ISO 13485:2016) and creating and submitting regulatory applications, and all regulatory agency interactions (e.g. FDA, Heath Canada, EU Notified Bodies and Competent Authorities, etc). (Investigation Device Exemptions (IDE); FDA Q-Sub process to obtain review group feedback; CE Marking; Labeling; Quality Assurance; Quality Engineering; ISO 13485 Auditing; V&V)

Technologies

NSOne Outlook Squarespace ECommerce Typekit Mobile Friendly Android Node.js SharePoint Flutter Python Splunk Domo Sisense KNIME

Keywords

pma contacting & corresponding to fda quality assurance regulatory strategy mdd to mdr remediation 510 remediation clinical evaluation reports ide & qsub clinical trial design irb application writing ra project management pma applications eu technical file writing gap assesment labeling verification & validation quality management system regulatory affairs clinical trial design amp irb application writing row regulations statistics cfr part 820 ce marking us 510 application mdd to mdr gap analysis quality engineering iso 134852016 audit sted medical equipment and supplies manufacturing qms development medical device post-market surveillance

Location

9214 US Highway 285, Morrison, Colorado, United States, 80465

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