Rocky Mountain Regulatory and Quality Partners

Regulatory affairs and quality assurance consulting firm with expertise helping medical device and IVD companies navigate the changing regulatory landscape including MDD to MDR gap assessment and remediation; developing regulatory strategies/submissions for bringing new products to market; Product/Process Verification and Validation; and building/maintaining quality management systems compliant to ISO 13485:2016, 21 CFR Part 820, the EU MDD/MDR, and Canadian regulations.

Consulting ServicesConformity AssessmentsRegulatory Intelligence