A medical device must be safe for its intended purpose. Medical device manufacturers must take measures to eliminate or reduce risks associated with their devices as far as possible, through a risk management assessment process. ISO 14971, “Medical devices - application of risk management to medical devices” describes the risk management process and reporting requirements. The risks associated with a medical device are assessable an/or measurable factors and are functions of the hazard severity and the probability that the hazard will occur. Risk management and analysis is required throughout the entire life-cycle of the product, in design, production and distribution processes, and for all medical devices regardless of their classification.
Medical Device Risk Management
is a regulatory requirement of Annex I “Essential Requirements” of the EU Medical Device Directives (Active Implantable, Medical Devices and In Vitro Diagnostics) . Note, it is also required by ISO 13485 “Medical devices - quality management system requirements for regulatory purposes” for processes in the supply chain leading to the final product.
ISO 14971 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
Using the ISO 14971 standard as a framework, and offers specialist consulting in your medical device risk management assessment. Our team of expert consultants have extensive experience in helping you to: identify risks and, through precise and prompt identification, to reduce risks for all classes of medical device and for all types of manufacturing processes. Drawing on a variety of risk analysis techniques and methodologies described in the ISO 14971 such as FMEA (Failure Mode and Effects Analysis) or FTA (Fault Tree Analysis), Arrowhead Consulting can manage, train you in, or carry out all the essential elements in the risk management process for you, including :
- Intended use of the medical device
- Origin and chemical composition
- Biocompatiblity and safety
- Packaging, transport and storage
- IFU ( Instructions for Use) Warnings
- (Pre) clinical
- Identification of the hazards related to the product or process, estimate of their probability of occurrence
- Estimation of the severity of each hazard and its associated risks
- Risk control and reduction measures and the monitoring of such measures.
- Writing a Risk Management report