ISO 14971 : Risk Management for Medical Devices
The approval of ISO 14971 for medical device risk management in December 2019 marked a significant milestone in ensuring the…
ICH Q9 : Quality Risk Management
ICH is the International Council for Harmonisation and deals with the harmanonization of technical requirements for pharmaceuticals for human use;…
ISO 22442 : Medical Devices containing Animal Tissues and Derivatives
Medical device containing substances or tissues derived from animals are important class of devices and they are highly regulated according…
The Risk Benefit Analysis
The benefit risk analysis is one of the key elements of the risk management process for medical devices and, more…
ISO 24971 : A Practical Guideline to Risk Management Process
It is impossible to deny the importance of risk management process for medical device organization and the recent publication of…
Risk Management Plan
The risk management plan is one of the key document for the risk management process for a medical device manufacturers…
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…
New ISO 14971: Updates for Risk Management
ISO 14971 for medical device risk management was approved in December 2019. Although no significant changes on the risk management…