WHAT WE DO...

Covering all development phases

CONCEPT & FEASIBILITY

From concept generation, to prototype design, construction and validation.

DESIGN & DEVELOPMENT

Complete design validation testing plans, protocols, test fixture design and tooling, test and reports, transition R&D devices to manufacturing (DHR, DMR, Design transfer)

RISK MANAGEMENT

Risk management plan and records according to ISO 14971, Design and process FMEA

DESIGN VERIFICATION

Plans, Protocols, test fixture design and manufacturing, test and reports, major testing management (verification, biocompatibility), Design transfer  (DHR, DMR)

VALIDATION

Packaging, sterilization, manufacturing Processes, shelf life, Transit, preclinical and clinical trials

REGULATORY

Consulting or complete hands-on partners to endorse the CE mark or FDA approval from strategy to market