Freyr Solutions (EC REP)
Freyr Solutions
★★★★★
4.3
/ 5
•
212 reviews
Freyr Solutions is an EU Authorized Representative (EC REP) specializing in medical device registration and marketing in Switzerland. They offer end-to-end regulatory support, including liaising with Swissmedic and ensuring compliance.
Freyr Solutions provides comprehensive regulatory support for medical and in-vitro device manufacturers seeking to register and market their products in Switzerland. As an appointed Swiss Authorized Representative (CH-REP), they handle the complexities of Swissmedic compliance, including reviewing technical files and representing devices on labeling. With a focus on end-to-end regulatory solutions, Freyr Solutions offers a step-by-step guide to appointing a CH-Rep and liaising with Swissmedic on your behalf. They also provide quarterly reports on CH-REP services and keep clients updated on Swiss medic regulations and their impact on the MedTech industry. Freyr Solutions has a global presence with offices in the USA, UK, EU, and India, ensuring regional support for their clients worldwide. They offer a 30-minute pre-purchase free consultation to discuss your specific needs and provide insights into navigating the Swiss regulatory landscape.
About
**Who they are**
Freyr Solutions (EC REP) is a regulatory consulting firm with over 15 years of experience, specializing in medical device registration and compliance. They offer end-to-end regulatory support for market entry and ongoing compliance.
**Expertise & scope**
* Medical Device Regulatory Consulting
* Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) regulatory compliance
* Market Access strategies and Authorized Representative support
* Post-Market Surveillance (PMS) services, including complaint handling, vigilance reporting, and PMS plan development
* Clinical Evaluation (CER) and Performance Evaluation (PER) services aligned with EU MDR and IVDR
* Quality Management System (QMS) services, including ISO 13485, MDSAP, and regional QMS requirements
* Regulatory support for the European market, with established presence in Germany, the UK, and Switzerland
**Reputation / proof points**
* Leverages an AI-first regulatory platform, freya fusion, for regulatory lifecycle management.
* Offers services across the entire regulatory lifecycle, from registrations and submissions to labeling and change control.
* Possesses expertise in navigating complex regulations such as EU MDR and IVDR.
Freyr Solutions (EC REP) is a regulatory consulting firm with over 15 years of experience, specializing in medical device registration and compliance. They offer end-to-end regulatory support for market entry and ongoing compliance.
**Expertise & scope**
* Medical Device Regulatory Consulting
* Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) regulatory compliance
* Market Access strategies and Authorized Representative support
* Post-Market Surveillance (PMS) services, including complaint handling, vigilance reporting, and PMS plan development
* Clinical Evaluation (CER) and Performance Evaluation (PER) services aligned with EU MDR and IVDR
* Quality Management System (QMS) services, including ISO 13485, MDSAP, and regional QMS requirements
* Regulatory support for the European market, with established presence in Germany, the UK, and Switzerland
**Reputation / proof points**
* Leverages an AI-first regulatory platform, freya fusion, for regulatory lifecycle management.
* Offers services across the entire regulatory lifecycle, from registrations and submissions to labeling and change control.
* Possesses expertise in navigating complex regulations such as EU MDR and IVDR.
Additional information
Freyr Solutions (EC REP) emphasizes a comprehensive, methodology-driven approach to regulatory compliance. Their services are designed to address the complexities of global market access for medical devices, including specific support for Software as a Medical Device (SaMD). They highlight the importance of continuous monitoring and proactive risk management through robust Post-Market Surveillance (PMS) and Clinical Evaluation Reports (CERs), which are treated as living documents essential for lifecycle management. The firm utilizes an AI-first platform, freya fusion, to streamline regulatory processes and manage the entire device lifecycle, from initial concept to post-market activities. Their presence in key European markets like Germany, the UK, and Switzerland facilitates navigation of regional regulatory landscapes.
Key Highlights
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Specializes in EU Authorized Representative (EC REP) services for medical devices.
Source
“Freyr Solutions is an EU Authorized Representative (EC REP) specializing in medical device registration and marketing in Switzerland.”
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Offers end-to-end regulatory support for medical devices, including market access and registration.
Source
“Freyr, as a proven Regulatory partner, provides end-to-end Medical Device Regulatory services that span across decoding Medical Device classification, compiling Device documentation, Medical Writing, Device Registration and acting as an in-country representative.”
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Provides comprehensive Post-Market Surveillance (PMS) services aligned with global regulations like EU MDR.
Source
“Freyr supports medical device companies with end-to-end post-market surveillance services, from complaint handling to PMSR/PSUR/PMCF reporting, helping businesses stay compliant...”
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Expertise in Clinical Evaluation (CER) and Performance Evaluation (PER) aligned with EU MDR and IVDR.
Source
“At Freyr, we offer end-to-end Clinical and Performance Evaluation Services for medical devices and in vitro diagnostics (IVDs), aligned with EU MDR 2017/745, IVDR 2017/746...”
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Leverages an AI-first regulatory platform, freya fusion, for regulatory lifecycle management.
Source
“freya fusion is Freyr’s flagship AI-first regulatory platform, designed to meet complex, real-world compliance needs.”
Certifications & Trust Signals
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Over 15 years of regulatory expertise.
Source
“Grounded in 15+ years of regulatory expertise and driven by advanced AI/ML.”
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Established presence in key European markets including Germany, the UK, and Switzerland.
Source
“Freyr has a strong presence in the European market with established delivery centers in Germany, UK, and Switzerland.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking EU Authorized Representative services.
- Companies requiring support with MDR and IVDR compliance.
- Developers of Software as a Medical Device (SaMD).
How engagement typically works
- End-to-end regulatory support.
- Project-based or ongoing compliance management.
- Leveraging AI-driven regulatory platforms.
Typical deliverables
- EU Authorized Representative services.
- Medical Device Registration dossiers.
- Post-Market Surveillance reports (PMSR, PSUR, PMPF).
- Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs).
- Quality Management System documentation and implementation support.
Good to know
- Best when requiring specialized regulatory expertise for complex markets like the EU.
- Most effective for companies needing to establish or maintain compliance with evolving regulations like MDR/IVDR.
HQ:
Princeton, USA
Languages:
English
Timezones:
America/New_York
Claim status:
Listed
Services & Capabilities
Best EU Authorized Rep (EC REP) | Compare & Get Quotes
Jurisdictions:
EU
Countries:
IE, DE, FR, NL
Industries:
Medical devices, IVD, Healthcare
Portfolio:
26-100, 100+
Onboarding time:
3–21 days
Pricing model:
Custom pricing
Starting from:
EUR 8,000
Included services:
EU Authorized Representative (EC REP) designation, Authority liaison and document availability support, Vigilance escalation and FSCA coordination, Labeling/EC REP identification review, Post-market support workflows (complaints, vigilance escalation)
Alternate Names:
CH-REP, Swiss Authorized Representative
Supports MDR:
Yes
Supports IVDR:
Yes
Device Classes Supported:
IVD
Post Market Support:
Yes
Labeling Review:
Yes
EU Entity Country:
Germany
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Fsca Recall Support:
Yes
Additional eu_ar Details
Device Classes Supported
Class I–III, IVD
Supports MDR
Yes
Supports IVDR
Yes
EU Entity Country
Germany, United Kingdom, Switzerland (Note: UK is no longer in EU but often considered in European regulatory context)
Fsca Recall Support
Yes
Post Market Support
Yes
Vigilance Contact Support
Yes
Onboarding Steps
The website content does not explicitly detail onboarding steps, required documents, or setup timelines.
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