• 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

Interaction of ISO 14971 with ISO 14155:2020

• December 11, 2020

First module of EUDAMED made available by the European Commission

• December 4, 2020

Considerations for IVDR classification

• December 2, 2020

Clinical Evidence Requirements for Legacy vs. Well-Established Devices under EU-MDR

• November 27, 2020

Clinical Data sources for Clinical Evaluation Reports

• August 17, 2020

Major FDA application types for medical devices

• August 14, 2020