Freyr Solutions (EC REP)
Freyr Solutions
★★★★★
4.3
/ 5
•
211 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 have established delivery centers in Germany, the UK, and Switzerland, positioning them to support market entry in Europe.
**Expertise & scope**
* End-to-end regulatory support for medical devices and IVDs.
* Expertise in Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) compliance.
* Services include Medical Device Registration, acting as an in-country representative, and navigating complex regulatory landscapes.
* Specialized support for Post-Market Surveillance (PMS), including complaint handling, vigilance reporting, and PMS documentation (PMSR/PSUR/PMCF).
* Conducting Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs) aligned with EU MDR and IVDR.
* Quality Management System (QMS) services, including ISO 13485:2016 compliance, MDSAP, and regional QMS requirements.
* Leveraging an AI-first regulatory platform, freya fusion, for managing the entire regulatory lifecycle.
**Reputation / proof points**
* Over 15 years of regulatory expertise.
* Presence across continents, with established offices in Germany, the UK, and Switzerland.
Freyr Solutions (EC REP) is a regulatory consulting firm with over 15 years of experience, specializing in medical device registration and compliance. They have established delivery centers in Germany, the UK, and Switzerland, positioning them to support market entry in Europe.
**Expertise & scope**
* End-to-end regulatory support for medical devices and IVDs.
* Expertise in Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) compliance.
* Services include Medical Device Registration, acting as an in-country representative, and navigating complex regulatory landscapes.
* Specialized support for Post-Market Surveillance (PMS), including complaint handling, vigilance reporting, and PMS documentation (PMSR/PSUR/PMCF).
* Conducting Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs) aligned with EU MDR and IVDR.
* Quality Management System (QMS) services, including ISO 13485:2016 compliance, MDSAP, and regional QMS requirements.
* Leveraging an AI-first regulatory platform, freya fusion, for managing the entire regulatory lifecycle.
**Reputation / proof points**
* Over 15 years of regulatory expertise.
* Presence across continents, with established offices in Germany, the UK, and Switzerland.
Additional information
Freyr Solutions (EC REP) emphasizes a comprehensive, methodology-driven approach to regulatory compliance. Their services are designed to address the complexities of evolving global regulations, such as the EU MDR and IVDR. They highlight the use of their AI-first platform, freya fusion, to streamline regulatory processes from submissions to lifecycle management. Buyers engaging Freyr can expect support in navigating country-specific requirements and ensuring adherence to international standards like ISO 13485. The firm's focus on end-to-end solutions aims to facilitate faster market access and sustained compliance.
Key Highlights
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Specializes in Medical Device Registration and acting as an EU Authorized Representative (EC REP).
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 and IVDs, including clinical and performance evaluations 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, and MEDDEV 2.7/1 Rev. 4 requirements.”
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Provides comprehensive Post-Market Surveillance (PMS) services, from complaint handling to reporting.
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, avoid recalls, and maintain market competitiveness.”
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Leverages an AI-first regulatory platform, freya fusion, for managing the entire regulatory lifecycle.
Source
“freya fusion is Freyr’s flagship AI-first regulatory platform, designed to meet complex, real-world compliance needs.”
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Has established delivery centers in Germany, the UK, and Switzerland to support European market access.
Source
“Freyr has a strong presence in the European market with established delivery centers in Germany, UK, and Switzerland.”
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.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking EU Authorized Representative services.
- Companies needing support with SaMD and SiMD regulatory compliance.
- Firms requiring assistance with post-market surveillance and vigilance reporting.
How engagement typically works
- End-to-end regulatory support.
- Leveraging AI-powered regulatory platform.
- Expert consultation and documentation services.
Typical deliverables
- EU Authorized Representative services.
- Medical Device Registration dossiers.
- Post-Market Surveillance Reports (PMSR/PSUR/PMCF).
- Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs).
- Quality Management System (QMS) documentation.
Good to know
- Best when requiring comprehensive regulatory support for medical devices in Europe and globally.
HQ:
Princeton, USA
Languages:
English
Timezones:
America/New_York
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
Additional eu_ar Details
Device Classes Supported
Class I–III, IVD
Supports MDR
Yes
Supports IVDR
Yes
EU Entity Country
Switzerland
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, timelines, or setup processes.
