Medical Device Regulatory Consulting

As a proven medical device Regulatory consulting firm, for nearly a decade, Freyr has been setting the industry standards in assisting Medical Device and IVD companies worldwide for end-to-end Regulatory needs and product registration.

COUNTRY-SPECIFIC MEDICAL DEVICE
REGULATORY CONSULTING

USA

  • 510(k) Premarket Notification
  • 513(g) Submission
  • US Agent

Canada

  • Medical Device Establishment Listing (MDEL)
  • MDSAP Compliance
  • Medical Device Listing (MDL)

Mexico

  • Device Registration
  • Sanitary Responsible Person (SRP)
  • Post Market Surveillance(PMS)

Brazil

  • Device Notifiication
  • Cadastro and Registro
  • BGMP Compliance

France

  • European Medical Device Classification
  • EU Authorized Representative (EC REP)

European Union

  • EU - ISO 13485:2016 compliance
  • CE Marking
  • EU MDR
  • IVDR Transition

Italy

  • ISO 14971 Risk Management Consultation
  • EU Medical Device Registration

Netherlands

  • In Vitro Diagnostic Regulation (IVDR)
  • Medical Devices Regulation (MDR)

China

  • Local Representation
  • Post Market Surveillance
  • Medical Device Registration

India

  • Indian Authorized Agent
  • Import License
  • Device Listing
  • Manufacturing License

Indonesia

  • Local Representation
  • Post Market Surveillance
  • Medical Device Registration

Japan

  • D-MAH / MAH Services
  • FMR Registration
  • Device Registration

Malaysia

  • CAB Assessment
  • MDA approval
  • Local Representation

South Korea

  • Local Representation
  • Post Market Surveillance
  • Medical Device Registration

Srilanka

  • Device Registration
  • Sample and commercial Import License
  • Local Representation

Taiwan

  • Local Representation
  • Post Market Surveillance
  • Medical Device Registration

Thailand

  • Local Representation
  • Post Market Surveillance
  • Medical Device Registration

UAE

  • Local Representation
  • Post Market Surveillance
  • Medical Device Registration

Vietnam

  • Local Representation
  • Post Market Surveillance
  • Medical Device Registration

Australia

  • Australian Sponsor Services
  • Conformity Assessment services
  • ARTG Listing

Saudi Arabia

  • Medical Device National Registry (MDNR) Listing
  • Medical Device Marketing Authorization (MDMA)
  • Saudi Arabia Authorized Representation

MEDICAL DEVICE REGULATORY CONSULTING –
A Comprehensive Portfolio

Medical Device Regulatory Consulting – Proven Expertise

As a medical device consulting and IVD Regulatory consulting organization, Freyr is uniquely positioned to deploy best vertical/divisional in-house experts to provide the best Regulatory approach, specifically for combination product portfolio companies. The customized nature of Freyr services is synchronized keeping in mind our customers’ growth strategy and product portfolio.

Freyr offers a robust combination of technology and Regulatory expertise to ensure product continuity, label compliance, and data quality. We are committed to partnering with companies by providing strategic guidance as they develop, advance and innovate devices. Here is a brief track record of Freyr.

  • 1400
    +
    Global Customers and Growing
  • 2300
    +
    Global Regulatory Experts
  • 120
    +
    Countries Constitute our Regional Medical Device Regulatory Services Portfolio
  • 325
    +
    Medical Device Companies Have Chosen Us as Their Strategic Partner
  • 3
    +
    Forbes Global Top 5 Medical Device Companies Have Chosen Us as Their Strategic Partner
 

MEDICAL DEVICE REGULATORY COMPLIANCE - INSIGHTS

Stay ahead of the curve with the latest updates on medical device registration, medical device classification, Health Authority Mandates, market trends and developments.

 

  • Blogs

    Top 5 Obstacles Encountered by Manufacturers in Medical Writing

    Read More

  • Case studies

    Regulatory Services for Medical Device Registration and LR Support in Thailand

    Read More

  • mandates

    CDSCO, India Has Included 8 New Device Types to The List of Regulated  Medical Devices.

    Read More

 

With an enormous experience in areas such as Medical device consulting, IVD regulatory consulting, Medical device compliance, and many more – Freyr brings to you the best in class industry experts for addressing all your regulatory requirements.

Need more clarity on your medical device Regulatory requirements? Book a meeting with our Industry experts!