Periodic Safety Update Report (PSUR) according to EU MDR 2017/745
One of the new requirement introduced with the EU MDR 2017/745 is the one related to the preparation of the Periodic Safety update Report (PSUR). This type of report is
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