Regulatory & Compliance.
Regulatory strategies and global market launch. Entourage helps you navigate complex regulatory requirements and bring your medical devices and in vitro diagnostic devices to market quickly and safely.
Our areas of focus.
Filter our expertise by your industry.
Market Approval & Strategy
MDR Consulting
Medical Device Regulation
DiGA Approval by the Federal Institute for Drugs and Medical Devices (BfArM)
Fast Track & Regular
IVDR Readiness
In Vitro Diagnostic Regulation
FDA Approval
US Market Approval
EU AI Act
AI Medical Devices & SaMD
Approval of ATMPs & biologics
Advanced Therapies
CE marking
MDR Certification
Market Access Strategy
AMNOG & Reimbursement
Regulatory Affairs
Strategic Approval
Quality, Audits & Regulatory Authorities
Post-Market & Surveillance
Compliance Operations & Systems
Risk Management
ISO 14971 Compliance
21 CFR Part 11 & Data Integrity
FDA IT Compliance
Annex 1 Consulting
Sterile manufacturing
Change Management Compliance
Change Control
Technical Writing
Technical Documentation
Qualified Person on Demand
Qualified person
Clinical Compliance
Clinical trials
Labeling & IFU creation
UDI & IFU
Discover more areas of expertise.
ENTOURAGE offers end-to-end solutions throughout the entire product lifecycle.
Quality Management
GMP- and ISO-compliant quality management systems and auditing.
ClusterClinical and Medical Affairs
Clinical strategies, study management, and PMCF.
ClusterR&D and Engineering
From research to design validation.
ClusterManufacturing & Supply Chain
Supply Chain Governance, Logistics, and GDP.
ClusterBusiness, Data & IT
Digitalization and IT Compliance (CSV, Part 11).