Project due diligence
Gap analysis for project components
Technical, regulatory and industrial structure
Product development plan
Market studies
Assistance for business plan/model definition
Advanced research
Reverse engineering
Technical expertise
Technical and functional specification
Identification and validation of critical parts
Product Design
System architecture
Regulatory constraints integration
Industrial constraints integration
Proof of concept (PoC)
Rapid prototyping, product prototyping
Test bench design & production
Verification & validation (V&V)
Regulatory constraints (CE/FDA) identification
Technical files production
Certification tests assistance
Design transfer
Traceability document production
QMS (ISO 13485, ISO 9001) set up assistance
CE MDR2017/745 assistance
FDA, 510k procedures production
21 CFR 820 (QSR) assistance
Industrialization study
Production files
Pre-series and series manufacturing
Setting up a production line
« fabless » services
Shipping & support (hardware, software)
