Software Development Plan According to IEC 62304:2006
The development of software for SaMD (Software As Medical Device) and SiMD (Software In Medical Device) is regulated through a…
Vigilance Reporting Requirements according to EU MDR 2017/745
Introduction Vigilance reporting is one of the pillars of post-market surveillance process for medical device. It belongs to the so-called…
PRRC (Person Responsible for Regulatory Compliance) and the EU MDR
The PRRC (Person Responsible for Regulatory Compliance) is one of the new requirement of the EU MDR European Medical Device…
ISO 11607 : Requirements for Sterile Medical Device Packaging
ISO 11607 plays a fundamental role in the requirements related to packaging for sterile medical device. The design of packaging…
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…
Risk Management Plan
The risk management plan is one of the key document for the risk management process for a medical device manufacturers…
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…
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…
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…
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…