Linking IVDR Performance Evaluations and Risk Management
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MDD Declaration of Conformity After 26 May 2021
As a regulatory representative for foreign manufacturers in the EU, UK, US, and Switzerland, MedEnvoy participated in several audits with…
Performance Evaluation Reports Under the IVDR
The performance evaluation report (PER) is the culmination of the application of the performance evaluation process to a specific IVD…
Ensuring Compliance for Foreign Manufacturers of CE Marked ‘Legacy Devices’: Common Pitfalls and Solutions
As a regulatory representative for foreign manufacturers including those who are CE marked ‘legacy device’ in the EU, Switzerland and…
Swissmedic Audit Reveals Compliance Issues with Class I Medical Device Manufacturers
Swissmedic, as expected, has started auditing and inspecting relevant economic operators. For example, Swiss-authorized representatives were subject to systematic…
The Relevance of Device Stability Studies to IVDR Performance Evaluation
Under the IVDR, the performance evaluation report (PER) is supported by three “sub-reports” comprising the scientific validity report (SVR),…
Technical Documentation Files Review: Top 5+ Mistakes by Manufacturers
As a regulatory representative for foreign manufacturers in the EU, UK, US and Switzerland, MedEnvoy reviews technical documentation files of…
Understanding Clinical Performance Reports(CPR) under the IVDR: A Guide for IVD Manufacturers
‘Clinical performance’ is not a novel concept in the transition from the IVDD to the IVDR; however, the applicability of…
Analytical Performance Characteristics for IVDs: What Manufacturers Need to Know
While ‘analytical performance’ is not a novel concept in the transition from the IVDD to the IVDR, it has been…
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