August 14, 2024
Find here an overview of risk management concepts and terminology under ISO 14971 and the MDR/IVDR. Plus, examples of how they’re applied in risk management.
October 24, 2023
Overview of Shelf Life, Expiration Dates, Device Lifetime/Useful Life and Service Life for medical devices and IVDs in Europe.
June 9, 2023
Page Last Updated: 9 August 2024 Definitions: Systems, Procedure Packs, Kits Systems and Procedure Packs MDR, Article 2(10): “‘procedure pack’ means a combination of products packaged […]
February 8, 2023
Find out the steps and timing to transfer your Swiss Authorized Representative (CH-REP) for medical devices and IVDs.
August 4, 2022
Find out how to create medical device Declarations of Conformity for Europe, the UK and Switzerland. Plus, Procedure Packs and Custom-made device statements.
February 21, 2022
Manufacturers selling in the EU, UK and Switzerland need to consider the different labeling requirements for listing their in-country representatives ...
January 18, 2022
Below is an overview of the Swiss Single Registration Number and how it applies to you. What is a Swiss ...
January 3, 2022
Do you need a European Free Sale Certificate for export, but not sure how to get one? Find out here who is allowed to request one, the cost and time.