Regulatory, Quality and Market Readiness Support for Medical Device and IVD Innovations

AMIQALY supports research organisations, start-ups, SMEs and innovation consortia developing medical devices and in vitro diagnostic (IVD) solutions. We provide regulatory and quality expertise to help translate innovative technologies into solutions with a clear pathway toward regulatory approval and market uptake.

Our support focuses on integrating regulatory and quality requirements early into the innovation process, helping projects avoid development gaps that could delay later validation, certification or commercialisation.

Expertise offered

• Regulatory strategy for medical devices and IVDs, including EU MDR and IVDR

• Regulatory pathway and classification assessment

• Quality management and quality-by-design considerations

• Identification of regulatory, technical and clinical evidence requirements

• Regulatory and quality implementation roadmaps

• Support in aligning R&D, validation and technology development with later regulatory requirements

• Regulatory input into Horizon Europe and other EU-funded innovation projects

• Contribution to exploitation and route-to-market planning