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Proving your medical device is safe and effective is key to ensuring that it will get to market. But beyond that, it's safe and effective functioning is critical to its enduring success.

A systematic assessment and mitigation of risks - in both the product design and the manufacturing process - is widely recognised as the central approach in ensuring that you consistently produce safe and effective products. Whilst not being prescriptive about the approach to follow, identifying and classifying potential harms and estimating the likelihood of occurrence gives the engineer a numerical tool for managing the risks.

We conduct these “risk assessments” for the whole process, from raw material/component manufacture through to final assembly and distribution.  These are then collated and form the basis of a Quality Control Plan – a structured and holistic tool within risk management which details how the identified risks are to be mitigated.

Our structured and methodical approach to risk management enables us to take medical devices from initial idea all the way through to pilot manufacture under our ISO 13485 accreditation.  Our experience ensures that an appropriate level of risk management is adopted for your product and enables this to be delivered in a time-efficient and cost-effective manner to optimise the balance of quality vs time to market.

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