Essential Performance in Medical Devices

Essential Performance in Medical Devices IEC 60601-1 describes essential performance as performance necessary to achieve freedom from unacceptable risk. This article aims to explain what the standard means by that and how this essential performance differs from basic...

Transitional Periods

MDR Transitional Periods In Article 120, the MDR establishes its transitional provisions, including the transitional periods. However, the descriptions of these transitional provisions and transitional periods are worded in a very complex manner. As a result,...

Hybrid seminars hybrid conferences

Hybrid seminars: why the majority fail With the coronavirus pandemic came hybrid seminars, hybrid workshops and hybrid conferences. They enable events to be held despite travel restrictions and limited participant numbers. But what at first glance appears to be an...

Insurance for Clinical Investigations

Insurance for Clinical Investigations Manufacturers who conduct clinical investigations of their medical devices must take out insurance. This requirement is established by the MDR and IVDR (among others). Find out how much insurance costs and what you should look out...