Research & Development and Engineering.
Accelerate your product development. We support you every step of the way, from the initial feasibility study through design controls to full verification and validation.
Our areas of focus.
Filter our expertise by your industry.
Design Controls
21 CFR 820.30
Usability Engineering
IEC 62366
Verification & Validation
Verification and Validation Testing
Prototyping
Medical Device Prototypes
Feasibility Studies
Feasibility studies
Biocompatibility Studies
ISO 10993
Software Development & SaMD
IEC 62304 · FDA SaMD
Cybersecurity & Embedded Systems
IEC 81001-5-1 · FDA Cybersecurity
IVD Performance Studies
IVDR Annex XIII · ISO 20916
Performance Evaluation Plan & Report
MDR Annex XIV · IVDR Annex XIII
Discover more areas of expertise.
ENTOURAGE offers end-to-end solutions throughout the entire product lifecycle.
Regulatory & Compliance
Regulatory strategies and global market launch.
ClusterQuality Management
GMP- and ISO-compliant quality management systems and auditing.
ClusterClinical and Medical Affairs
Clinical strategies, study management, and PMCF.
ClusterManufacturing & Supply Chain
Supply Chain Governance, Logistics, and GDP.
ClusterBusiness, Data & IT
Digitalization and IT Compliance (CSV, Part 11).