MedTech Standard Adherence
introductionOur expertise and knowledge of the ISO/IEC MedTech standards relating to usability is unmatched. Interpretation and process design is key and we can direct you accordingly so you don’t waste time on what is not a requirement.
medtech standard adherence
Application of Usability Engineering
IEC 62366:2015 specifies a process to analyse, specify, develop and evaluate the usability of a medical device as it relates to safety. This usability engineering process enables Movement to assess and mitigate risks associated with use errors to result in a design that is safe and easy to use. Movement’s process is based on this standard and it is our internal design QC certification. Movement is unique in providing a human focused, innovative design service whilst maintaining stringent documentation.
medtech standard adherence
Application of Risk Management
ISO 14971:2007 specifies a process to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device. Movement’s design development programme links the requirements and documentation of this with our documented outputs from IEC 62366.
medtech standard adherence
ANSI/AAMI HE75 Guidelines
The purpose of these guidelines is to provide a relevant source of HFE information and design criteria for medical devices. The human factors design information and methodologies described here may be used during every phase of device design and development, from initial conceptualization through to post-market surveillance. Movement use these guidelines in combination with a myriad of other publications, standards, knowledge and expertise. Movement improve on these guidelines based on newly discovered HFE insights and design requirements.
medtech standard adherence
UEF
The template will be created for the UEF and will commence with the Usability Requirements from the very first stages of the project. This comprehensive file becomes our client’s submission for the ISO/IEC 62366 and related ISO/IEC 14971 standard. Movement manage and deliver the UEF for inclusion into our clients’ QC documentation relating to their HFE Plan & Product Realisation for ISO 13485:2003. This is an exceptionally efficient process and removes an enormous burden from our client’s administration workload.
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