This service is applicable to EIC beneficiaries who require creative, pragmatic, time and cost-saving modelling, testing and prototyping, particularly in the exploratory or design phase of product development. The service provides a customied bench testing, including electronic, software modelling and life cycle simulation, or other assessment of product safety and efficacy; Development of device proof-of-concepts and prototypes (machined or 3D printed); Usability testing (usability engineering file, patient/HCP interviews); Piloting of external Verification and Validation tests such as packaging, shelf life, biocompatibility, microbiology or other mechanical and environmental tests; Clinical evaluation, including CEP/CER/PEP/PER in accordance with MDR/IVDR, and interaction with Competent Authorities and Ethical Committees for the clearance of clinical investigations. 

As a result of the service, a Design History File and associated documentation will be prepared for the EIC beneficiaries. 
The benefits of the service are, a) De-risks product development by providing valuable test data at low cost to corroborate or augment larger test programs; b) Allow manufacturers to focus on developing core products; c) Ensure products are developed with users in mind. 

The service may take between 2 weeks to 6 months, depending on scale and complexity of projects. Project management is provided to ensure that overall development timelines are met.