Services

Innovation Management

Innovation valorization
Due diligence for projects or innovation companies
Gap analysis for project components
Technical and regulatory structure
Product development plan
Market studies
Assistance for business plan/model definition

Product R&D (electronics, software, mechanical)

Advanced research
Reverse engineering
Technical expertise
Technical and functional specification
Architecture design
Regulatory constraints integration
Industrialization constraints integration
Identification and validation of critical parts
Proof of concept (PoC)
Prototyping
Test bench design and production
Verification & validation (V&V)

Regulatory & Quality

Regulatory constraints (CE/FDA) identification
Technical files production
Certification tests assistance
Design transfer
Traceability document production
QMS (ISO 9001, ISO 13485) set up assistance
CE MDR2017/745 assistance
FDA, 510k procedures production
21 CFR 820 (QSR) assistance

Industrialization

Industrialization study
Production file
Pre-series, small series production
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