The European Medical Device Directive (Annex I clause 2) requires that manufacturers of medical devices:
- Eliminate or reduce risks as far as possible, so they have inherently safe design and construction (Where a design change can be made to mitigate a risk, it must be made, regardless of economic factors)
- Where appropriate, take adequate protection measures (including alarms if necessary) in relation to risks that cannot be eliminated
- Inform users of the residual risks or shortcomings of the protection methods adopted (however this activity cannot be used to reduce the overall risk of a particular hazard).
Adherence to the harmonised standard ISO 14971:2012 ensures that these requirements are met. Previous versions of this standard have made allowance for risks to be reduced to be as low as reasonably practical (ALARP) however the 2012 version requires that risks are reduced to as low as possible (ALAP).
With the new ISO 13485:2016 standard, a risk based approach to all QMS processes for your organisation is required. Having the ability to perform risk assessments quickly and routinely will be a major benefit to your QMS.
QCS has the expertise to train staff effectively in the use of these risk management requirements, to facilitate sessions or provide consultancy to ensure your products meet regulatory requirements in relation to risk.
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