The Field Safety Notices under the MDR and the IVDR (Art. 89(8)/84(8))

The Post-Market Surveillance (PMS) Plan under the MDR and the IVDR (Art. 84/79)

The Certificate of Free Sale under the MDR and the IVDR (Art. 60/55)

The EU Declaration of Conformity (DoC) under the MDR and the IVDR (Art. 19/17)

The General Obligations of Manufacturers – Financial Coverage – under the MDR and the IVDR (Art. 10)

Key Concepts of Medical Device Design Development

Three Essential Steps to Getting a Device to the U.S. Market

The Clinical Evidences: Definitions and Elements under the IVDR

Linguistic Requirements under the MDR and the IVDR

EU’s Governmental Bodies