Medical Device Regulatory Services in
The Americas

Overview

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.

Our Presence

Expertise

Freyr Expertise

  • 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
Freyr Advantages

ADVANTAGES

Freyr Advantages

 

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.