Freyr Solutions (EC REP)
Freyr Solutions
★★★★★
4.3
/ 5
•
213 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 expertise, specializing in medical device registration and market access globally. They leverage an AI-first regulatory platform, freya fusion, to manage the entire regulatory lifecycle.
**Expertise & scope**
* End-to-end regulatory support for medical devices, IVDs, and SaMDs.
* Expertise in navigating complex European regulations, including EU MDR and IVDR.
* Services encompass device classification, dossier authoring, registration, labeling, artwork, intelligence, and change control.
* Specialized services include Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) compliance.
* Post-market surveillance (PMS), including complaint handling, vigilance reporting, recalls, corrections, and removals.
* Clinical and Performance Evaluation (CER, PER) services aligned with EU MDR/IVDR and MEDDEV guidelines.
* Quality Management System (QMS) services, supporting standards like ISO 13485:2016, MDSAP, and others.
* In-country representation and Authorized Representative services.
* Global market access support across over 120 countries.
**Reputation / proof points**
* Leverages 15+ years of regulatory expertise.
* Operates an AI-first regulatory platform, freya fusion.
* Maintains established offices in Germany, the United Kingdom, and Switzerland.
Freyr Solutions (EC REP) is a regulatory consulting firm with over 15 years of expertise, specializing in medical device registration and market access globally. They leverage an AI-first regulatory platform, freya fusion, to manage the entire regulatory lifecycle.
**Expertise & scope**
* End-to-end regulatory support for medical devices, IVDs, and SaMDs.
* Expertise in navigating complex European regulations, including EU MDR and IVDR.
* Services encompass device classification, dossier authoring, registration, labeling, artwork, intelligence, and change control.
* Specialized services include Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) compliance.
* Post-market surveillance (PMS), including complaint handling, vigilance reporting, recalls, corrections, and removals.
* Clinical and Performance Evaluation (CER, PER) services aligned with EU MDR/IVDR and MEDDEV guidelines.
* Quality Management System (QMS) services, supporting standards like ISO 13485:2016, MDSAP, and others.
* In-country representation and Authorized Representative services.
* Global market access support across over 120 countries.
**Reputation / proof points**
* Leverages 15+ years of regulatory expertise.
* Operates an AI-first regulatory platform, freya fusion.
* Maintains established offices in Germany, the United Kingdom, and Switzerland.
Additional information
Freyr Solutions (EC REP) provides comprehensive regulatory support throughout the entire medical device lifecycle. Their services are designed to ensure compliance with evolving global regulations such as EU MDR and IVDR, as well as FDA post-market requirements. They emphasize proactive risk detection and continuous real-world monitoring, incorporating industry trends like real-world evidence and digital vigilance. For European market entry, they offer specific services for medical device registration, acting as an EU Authorized Representative and navigating complex regional requirements. Their approach integrates QMS, clinical evaluations, and post-market surveillance to facilitate faster market entry and sustained compliance.
Key Highlights
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Offers end-to-end regulatory support for medical devices, IVDs, and SaMDs.
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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Specializes in navigating complex European regulations, including EU MDR and IVDR.
Source
“Freyr offers top-notch Regulatory support for medical device registration in Europe, a crucial market with intricate and rigorous regulations in place.”
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Provides comprehensive post-market surveillance (PMS) services.
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 regulatory lifecycle management.
Source
“freya fusion is Freyr’s flagship AI-first regulatory platform, designed to meet complex, real-world compliance needs. Grounded in 15+ years of regulatory expertise and driven by advanced AI/ML.”
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Offers Clinical and Performance Evaluation services aligned with EU MDR/IVDR.
Source
“At Freyr, we offer end-to-end Clinical and Performance Evaluation services for medical devices, in vitro diagnostics (IVDs), and SaMDs, aligned with EU MDR 2017/745, IVDR 2017/746, and MEDDEV 2.7/1 Rev. 4 requirements.”
Certifications & Trust Signals
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Founded with over 15 years of regulatory expertise.
Source
“Grounded in 15+ years of regulatory expertise and driven by advanced AI/ML.”
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Maintains established offices in Germany, the United Kingdom, and Switzerland.
Source
“With established offices in Germany, the United Kingdom (UK), and Switzerland, Freyr aids in navigating Regulatory hurdles and ensuring adherence to compliance standards.”
Buyer Snapshot
Best for
- Medical device, IVD, and SaMD manufacturers seeking global market access.
- Companies needing EU Authorized Representative services.
- Businesses requiring end-to-end regulatory lifecycle support.
How engagement typically works
- Project-based regulatory consulting.
- Retainer for ongoing lifecycle management.
- Leveraging AI-powered regulatory platform.
Typical deliverables
- Regulatory strategy and roadmapping.
- Dossier authoring and submissions.
- Post-market surveillance reports (PMSR, PSUR, PMPF).
- Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs).
- Quality Management System documentation.
- EU Authorized Representative services.
Good to know
- Best when requiring specialized expertise in European medical device regulations (MDR/IVDR).
- Ideal for companies needing to establish a presence in complex markets.
- Requires clear definition of device classification and intended use for accurate pathway selection.
HQ:
Princeton, USA
Languages:
English
Timezones:
America/New_York
Claim status:
Listed
Services & Capabilities
Find 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, IIa, IIb, III, IVDs, SaMD
Supports MDR
Yes
Supports IVDR
Yes
EU Entity Country
Switzerland
Fsca Recall Support
Yes
Post Market Support
Yes
Vigilance Contact Support
Yes
Onboarding Steps
Onboarding involves understanding device classification, compiling documentation, and regulatory strategy, with services customized for end-to-end approvals.
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