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Creating the safest possible product (& system) is essential when designing a Medical Device.

ISO 14971 is an international standard that provides a framework for risk management specifically for medical devices. It outlines the terminology, principles, and processes necessary to identify, evaluate, control, and monitor risks associated with medical devices throughout their lifecycle.

Having extensive experience with complex medical device products & systems (including Software as a Medical Device (SaMD)), the team at Medical Design Group Ltd have created a Risk Management Process in line with ISO 14971 that is apparent throughout the full lifecycle of a development.

Comprehensively addressing Risk Management throughout the entire product design & development process helps to ensure the products we create have ultimately reduced the probability of occurrence of harm & the consequences of that harm; therefore, we can be confident that the products Medical Design Group create for our clients are safe, acceptable for market release and provide real-life benefits to users & patients alike.

Our product development process entwines:

• Early-stage research
• Concept development
• Detailed design & development stages
• Usability & Human Factors Engineering (Task Analysis, Known Problem Analysis, Formative & Summative Usability Evaluations)
• Risk Management practices (Risk Analysis, FMEA(s), Verification & Validation testing, Toxicological Risk Assessment)

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