Evnia summarizes MDCG 2023-7

• February 9, 2024

Article 61(10): When is a Clinical Evaluation possible without Clinical Data?

• February 1, 2024

FDA updates their eSTAR templates to submit certain PMA applications

• January 12, 2024

Summary of MDCG 2021-6 Rev.1

• December 13, 2023

MDR Transition Periods – Knowledge Map

• November 3, 2023

List of Regulatory Authorities around the world

• August 28, 2023

• e-book

Person Responsible for Regulatory Compliance: The ”Article 15 Man”

• April 23, 2021

MDR-compliant Labels

• April 5, 2021

Bayesian Statistics in Medical Devices

• March 25, 2021

Searchable spreadsheet for FDA product codes

• March 19, 2021

Regulation of Companion Diagnostics in the US and in IVDR

• January 20, 2021

Summary of Safety and Clinical Performance (SSCP) in a nutshell

• January 8, 2021