Services

Innovation Management

Market access
Due diligence for projects or innovation companies
Gap analysis for project components
Technical and regulatory structure
Clinical and medico-economic structure
Product development plan
Key stakeholders strategy
Business model / Business plan

Clinic / Medico-economic

Positioning vs current practice
Performance/security criteria definition
Clinical benefit criteria definition
Medico-economic benefit criteria definition
Structure CER
Clinical strudies design
Medico-economic studies (SNDS) design
Studies production
Biocompatibility advising
CER production
Innovation fast track execution (France – article 51)

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
CER production
Medical/biocompatibility file production
SMQ (ISO 9001, ISO 13485) set up assistance
CE MDR2017/745(746) assistance
FDA, 510k, PMA procedures production
Preparation to meeting with notified body / FDA

Industrialization

Industrialization study
Production file
Pre-series, small series production
« fabless » services