Accelerate your Medical Device Project
From planning to market access, add extra resources at the right time to hit the market faster.
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