Developing for Market Clearance
Strategies & plans for proof of concept (POC), performance, safety, & functionality testing for the defined Intended Purpose / Indications for Use. Identifying standards and verification testing plans for materials, manufacturing / assembly processes, packaging & labelling & sterilisation. At the earliest stage, supporting manufacturers & distributors address and meet EU regulations (EU) 2017/745 (MDR), 746 (IVDR), UK MDR, standards and/or common specifications for CE, UKCA & UKNI & other countries’ requirements
Expert resources, advices, planning and development to implement best fit practices and controls for:
POC including technology application re: clinical need, indications for use & application
Specification development, definition, including Human Factors, User and Interface Requirements
Identification of national and international standards for test.
Materials selection, biocompatibility & testing protocols
Specific country applications / clearances e.g. US, EU, UK & other countries.
Software Life-Cycle to meet IEC62304
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