Functional Safety in Medical Devices
Functional safety is critical in the medical device industry and covers every step of a device’s lifecycle.From concept and design, through hazard analysis and risk assessment, reaching to the definition and development of the safety requirements, specification and implementation.In XEFRA we understand that each component’s or subsystem function contributes to the device’s overall safety, we integrate functional safety methods and procedures across every part that the device engages, controls or monitors.Dangerous failures may arise from various sources such as incorrect specifications of the system, hardware, or software; and omissions in the safety requirements specification in the first place.The ultimate manufacturer’s goal is to design the medical device lifecycle in a preventive manner, preventing dangerous failures or being able to control them if/when they occur.
Medical Devices Safety Standards and Risk Management
Recognising the complexity of the medical device industry, we place a strong emphasis on risk management.
Medical device development and manufacturing is an extensive regulated sector.
We guide medical device manufacturers through all the relevant rules, national and international regulations and standards relevant to a specific device intended to be developed and destined to the general public use.
XEFRA is able to guide you through hazard analysis and risk assessment, under the FS approach, in order to develop the apropriate safety requirements for your medical devices, from design and implementation, to operation and maintenance, arriving to the final decommissioning and/or disposal.