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About
Evnia Group
Corporate Responsibility
Code of conduct
Quality Policy
Ventures
Lifecycle Management
Real World Evidence (RWE)
RWE for medical devices
Registries
Clinical Experience Data
PMCF Surveys
Clinical Evaluation Reports
PMCF Plans
Technical Documentation
In-Vitro Diagnostics Regulation (IVDR)
Regulatory Affairs Management
Solutions
Iris
Triad
Authorised Representative
EVA – evnia vigilance algorithm
Management
Resources
Original Publications
News
Industry Insight
Videos
EU Regulations and Guidances for medical devices and IVDs
International Regulations and Guidances
Newsletters
Clients
Careers
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Industry Insight
Summary of the main points of MDCG 2020-13
July 28, 2020
Conformity Assessment Routes applicable to EU-MDR
July 28, 2020
Checklist to use before starting to write a CEP/CER
July 28, 2020
IVDR General Safety and Performance Requirements
July 28, 2020
Checklist for EU-MDR Technical Documentation
July 28, 2020
State of the Art in EU-MDR
June 21, 2020
How Will ISO 13485 Guide You Towards EU-MDR Compliance
June 16, 2020
EU-MDR Checklist: Major Documents & Requirements
June 16, 2020
Aspects to Consider When Defining the Need for PMCF Studies
June 13, 2020
MDCG 2020-12 : EU-MDR and Drug-Device Combinations
June 13, 2020
Risk Management At Every Level Of Your Quality System
June 12, 2020
Infographics: Mandatory Reporting Requirements Under MDR
May 29, 2020
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HOME
ABOUT
Evnia Group
Corporate Responsibility
SERVICES
Clinical Evaluation Reports
PMCF Planning
Technical Documentation
In-Vitro Diagnostics Regulation (IVDR)
Regulatory Affairs Management
Clinical Experience Data
Ventures
RESOURCES
Original Publications
News
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Videos
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