What types of risks are covered by Risk management? It covers the harms related to patients, users or/and environment. What is the difference between Design controls and Risk management? Design Controls prove that the Medical Device is safe, effective and meets the...

What is Vigilance? It is a system for the notification and evaluation of incidents and Field Safety Corrective Actions (FSCA) involving Medical Devices. (MEDDEV 2.12-1, rev.8) What steps shall the manufacturer follow to report an incident? Technical documentation...

Classification of software as a Medical device under Medical Device Regulation (European Union)  The first step is to determine whether your software is a Medical Device.   How do you determine if...

Temporary authorizations issued in response to the COVID-19 pandemic FDA enforces policy for infusion pumps and accessories during the coronavirus disease 2019 To help facilitate the availability of infusion pumps, the FDA does not intend to object to limited...