Risk Management Plan
The risk management plan is one of the key document for the risk management process for a medical device manufacturers and it is essential to understand the requirements that are
The PMCF (Post-Market Clinical Follow-Up) according to EU MDR 2017/745
The PMCF - Post Market Clinical Follow-up is part of active modalities to perform post-market surveillance activities and the requirements related post-market clinical follow-up plan and report have been further
ISO 45001: Management of Safety and Occupational Health
The ISO 45001 is a standard related to the management of occupational health and safety; here we provided an overview of ISO 45001 clauses, requirements, a list of documentation requested
FMEA Technique for Risk Analysis
FMEA (Failure Mode Effect Analysis) is definitely the most widely used method for assessment of risks associated two any type of devices and processes. This is valid for any type
Brexit and UKCA Mark for Medical Devices
Due to Brexit, UK will not recognised CE mark for medical devices and an UKCA mark and the related UKCA conformity assessment will be mandatory to place medical devices in
