Methodology applied to consumer and industrial design tasks

Methodology applied to consumer and industrial design tasks

Industrial and consumer design follows an ISO9001 compliant process. Starting from a feasibility study based on user requirements and essential requirements, the design phase starts and goes over in the system integration and prototyping phase to end in a fully validated and certified product. The complete development process is under the control of technical documentation and a dedicated development team with an appointed project manager. After certification, production can start.

Methodology applied to medical design tasks

Medical electronics design being for a medical device or for an active implantable medical device (AIMD) is executed within the framework of the medical device directive, MEDDEV 93/42/EEC or AIMD 90/389/EEC. It therefor follows an ISO13485 compliant process. An important additional element in the design of a medical product is the risk assignment along the complete engineering and production cycle. Hence, the feasibility study is based on user and essential requirements together with specifications resulting from an ISO14791 compliant risk analysis. At design phase, Software design must be medical grade and follows the ISO62304 methodology. Further in the chain, at integration and validation phase, next to technical and functional testing, preclinical and clinical testing compliant to ISO14155 are important steps to achieve product certification by the Notified Body. Along the complete design and engineering cycle Zenso foresees in an up to date risk management file and technical file.