Overview
The European region is considered the second largest market, after the US, for medical devices. At the same time, Europe has a very complex and stringent regulatory compliance. From the implementation of MDR, Brexit to Swixit, Europe has experienced volatility in terms of regulations, especially for medical devices.
Freyr has a strong presence in the European market with established delivery centers in Germany, UK, and Switzerland. Freyr covers the entire spectrum of Regulatory support for Medical Devices to market products in these stringently regulated countries.
Our Presence
Expertise
Freyr Expertise
- Regulatory strategy for EU MDR/IVDR transition from Directive
- Comprehensive European Medical Device Regulation (EU-MDR) Compliance & Transition consulting
- Comprehensive European In Vitro Medical Device Regulation (EU-IVDR) Compliance & Transition consulting
- Product Classification and Registration services
- ISO 13485:2016 Compliance and Certification
- ISO 14971:2019 Risk Management
- MDSAP Compliance and Certification
- European Authorized Representative (EAR)
- UK Responsible Person
- Ch-Rep
- Remediation and action plan for Brexit transition
- Gap Analysis of technical documents & quality management systems
- Regulatory support for Technical File Compilation [CE Technical File, UKCA Technical File]
- Regulatory support for product development documents such as design history files
- Health Agency and Notified Body liaising and support
- EUDAMED Compliance
- UDI Implementation
- Labelling Compliance
Freyr Advantages
ADVANTAGES
Freyr Advantages
Successful submissions for varied class of devices ranging from simple Class I devices to complex devices such as, Class III devices, Implants, SaMDs
Local affiliate access to meet challenges of authority and language specific requirements
Dedicated Medical Writing team for CE projects
Dedicated personnel to provide Medical Device and IVD Regulatory support
In-country or legal representative support with a cost-effective model
Exclusive delivery center in the UK
