As technology improves, this presents new complexities and hazards to the system. Therefore, medical electrical equipment must be compliant with applicable standards to protect individuals within medical facilities from potential electrical harm.
Where risk management and medical device safety meet: 24 definitions you need to know.
What is Risk Management? Here is a beautiful presentation to help you understand what Risk Management in Medical Devices looks like in compliance with ISO 14971; the standard for the application of risk management to medical devices.
Risk Management is defined as the “systematic application of management policies, procedures and practices to the tasks of analyzing evaluating controlling, and monitoring risk” Basically, risk management means the right people doing the right activities at the right time to prevent harm.
Creating your design input specification (DIS) should be the first stage of any product design process. It is a vital tool your Design Team will use as the framework for the design and development of your medical device, and to also comply with regulatory requirements. Wait! Just what is DIS? In the simplest terms, your… Continue reading How to turn User Needs into Design Specifications (with tables)
A design input specification (DIS) plays a critical role in any product design process. The product DIS contains all the characteristics of a device that are used as a basis for product design. The level of detail that your design inputs cover can be the deciding factor that makes or breaks a smooth run to… Continue reading KICKSTART YOUR DIS: 6 Approaches to Generate Design Inputs