Are you or your company responsible for high level risk analysis, which includes critical characteristics on disposable medical devices?
For complex medical devices, risk analysis is sometimes required to be in compliance with ISO-14971:2012 and MDD/93/42EEC. These are two medical device risk analysis knowledge bases. ISO-14971 is an international standard and MDD/93/42/EEC is the law.
Does your company have to detail all phases of your risk and hazard considerations prior to your production processes to be compliant? The purpose of ISO-14791:2012 risk analysis is very similar to that of an FMEA (Failure Modes & Effects Analysis); only this time you must consider risk and hazards as they would potentially harm the end user.
The ATL White Paper “What is ISO-14971 & MDD/93/42/EEC Risk Analysis for Medical Devices (CE Mark)” attempts to explain some of the risks and hazards you must consider so the people using the medical device are protected from potential hazards.
Click here to view the white paper on Risk Analysis for disposable medical devices.