Developing for Market Clearance

Strategic planning for proof of concept (POC), performance, safety, & functionality testing for the defined Intended Clinical Indications for Use. Identifying key user, regulatory requirements, applicable standards and verification testing plans for design, components, materials, manufacturing / assembly processes, packaging & labelling & sterilisation. Supporting manufacturers & distributors address and meet EU regulations (EU) 2017/745 (MDR), 746 (IVDR), UK MDR, standards and/or common specifications for CE Mark, UKCA Mark & UKNI Mark & other national 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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