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Medical Device Regulatory Services in Europe
Pharma Wizard offers top-notch Regulatory support for medical device registration in Europe, a crucial market with intricate and rigorous regulations in place. With established offices in Germany, the United Kingdom (UK), and Switzerland, Pharma Wizard aids in navigating Regulatory hurdles and ensuring adherence to compliance standards.
Medical Device Regulatory Services in Europe 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.
Pharma Wizard has a strong presence in the European market with established delivery centers in Germany, UK, and Switzerland. Pharma Wizard covers the entire spectrum of Regulatory support for Medical Devices to market products in these stringently regulated countries.
Pharma Wizard has a strong presence in the European market with established delivery centers in Germany, UK, and Switzerland. Pharma Wizard covers the entire spectrum of Regulatory support for Medical Devices to market products in these stringently regulated countries.
Pharma Wizard Medical Device EU Services for End-to-End Compliance
CE Marking
CE Marking services for medical device CE Certification.
EU MDR
EU MDR 2017/745 regulatory compliance solutions, tailored to your needs.Ā
EU IVDR
Tailored EU IVDR 2017/746 regulatory compliance solutions as per your requirements.
European Authorized Representative
European Authorized Representative Services (EC REP) for appointing a EAR
Clinical and Performance Evaluation
Comprehensive Clinical and Performance Evaluation for medical devies and IVDs.
Medical Device Regulatory Services in Europe
- Expertise
- Advantages
- 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 servicesāÆ
- 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
- 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