U.S. & Canada are the most lucrative markets for medical devices in terms of market acceptance as well as in terms of existent regulations required for necessary licenses and approvals. With a strong demand for high-quality medical device technologies, the U.S. and Canada markets continue to attract manufacturers worldwide. But tracking, decoding, and aligning with region-specific medical device Regulatory requirements, at times, poses a challenge for manufacturers, if not implemented intelligently. For example, U.S. requires all importing companies to appoint a registered U.S. agent to act as a connection between the company and the USFDA.
Head quartered in Princeton, NJ, U.S., Freyr has strong capabilities in the region and provides end-to-end Regulatory support to varied classes of Medical Devices ranging from software based to In-Vitro Diagnostic (IVD) Devices.
- Regulatory and Market Intelligence Support
- Product Classification as per Regulatory requirements
- USFDA 513 (G) & Device Registration Pathway (Right Pathway among 510 (K)/De-NOVO/PMA/IDE)
- Pre-Submission Meeting with Health Agencies
- Regulatory Support for Product Documents such as, Design History File (DHF)
- Gap Analysis of the Technical Documents & Good Manufacturing Practice (GMP) Systems
- Regulatory Support for Technical File Compilation as required by respective Registration Pathway
- USFDA Quality System Compliance Strategy (21 CFR 820)
- Medical Device Single Audit Program (MDSAP) compliance services
- Health Canada-Medical Device License (MDL) and Medical Device Establishment License (MDEL) Registration
- Health Agency Liaising and upport
- In-Country Representation – U.S. Agent and Sanitary Responsible Person Services
- Post Approval Compliance activities
Successful submissions for varied class of devices ranging from software to sutures
Local affiliate access to meet the challenges of authority and language-specific requirements
Dedicated and expert personnel to provide Medical Device and IVD Regulatory support
Cost-effective model for In-country or Legal representation support
Have successfully delivered various projects across U.S. and Canada
Headquartered in the U.S.