Services

Development Strategy

Project due diligence
Gap analysis for project components
Technical and regulatory structure
Product development plan
Market studies
Assistance for business plan/model definition

Product R&D

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 & Quality

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

Industrialization study
Production file
Pre-series and series production
Setting up a production line
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