Regulatory Insight
Regulatory Insight is a global leader in FDA medical device consulting, compliance, submission, training, and export/import services. With over 25 years of experience, they assist medical device and IVD companies worldwide in obtaining regulatory approvals, ensuring compliance with international standards, and providing tailored training and consulting services. Their mission is to help companies navigate complex regulatory landscapes efficiently and cost-effectively, supporting their clients from start-up to Fortune 500 corporations.
Industries
Nr. of Employees
small (1-50)
Regulatory Insight
Greenwood Village, Colorado, United States, North America
Services
End-to-end preparation and filing of regulatory market applications and related pre-submission interactions for U.S., Canadian, European, and Australian markets.
Creation and customization of quality system documentation and processes to meet FDA and ISO requirements, including gap analyses and remedial implementation.
Internal, supplier, MDSAP and EU MDR audit services, pre-inspection readiness assessments, and support during regulatory inspections.
Customized training on quality systems, regulatory submissions, design controls, and process validation delivered onsite or remotely with training records provided.
Registration of importers and foreign establishments, device listing, resolution of customs/import holds, export certificate procurement, and acting as designated U.S. Agent for foreign manufacturers.
Determination of required safety and performance tests for submissions and coordination with testing laboratories for electrical safety, EMC, mechanical, biocompatibility, sterility, stability, and other tests.
End-to-end preparation and filing of regulatory market applications and related pre-submission interactions for U.S., Canadian, European, and Australian markets.
Creation and customization of quality system documentation and processes to meet FDA and ISO requirements, including gap analyses and remedial implementation.
Internal, supplier, MDSAP and EU MDR audit services, pre-inspection readiness assessments, and support during regulatory inspections.
Customized training on quality systems, regulatory submissions, design controls, and process validation delivered onsite or remotely with training records provided.
Registration of importers and foreign establishments, device listing, resolution of customs/import holds, export certificate procurement, and acting as designated U.S. Agent for foreign manufacturers.
Determination of required safety and performance tests for submissions and coordination with testing laboratories for electrical safety, EMC, mechanical, biocompatibility, sterility, stability, and other tests.
Expertise Areas
- Regulatory submission strategy and preparation
- Quality management systems (ISO 13485 / FDA 21 CFR Part 820)
- MDSAP audit preparation and auditing
- Inspection readiness and regulatory remediation
Key Technologies
- FDA 21 CFR Part 820 (Quality System Regulation)
- ISO 13485 quality management systems
- Medical Device Single Audit Program (MDSAP) framework
- EU Medical Device Regulation (MDR) technical documentation