Medical Consultancy & Engineering | Medical Software & Compliance Experts
Building compliant and secure medical software
Medinex helps medical technology companies develop compliant software, implement quality systems and navigate complex regulatory frameworks.
IEC62304
Medical software lifecycle processes.
ISO13485
Medical devices QMS.
MDR / IVDR
European medical device regulations.
ISO14971
Risk management for medical devices.
ISO27001 / GDPR
Securely processing of medical data.
ISO42001
Artifical Intelligence in medical devices.
Services
We provide both strategic as well as technical knowledge for compliant solutions.
Medical Software Development
IEC62304 compliant development for regulated healthcare software.
Project Management
Medical device product development guidance.
Information Security
ISO27001 / NEN7510, audit readiness assessment.
Risk Management
ISO14971, FMEA and usability engineering assistance.
MDR / IVDR Compliance
Regulatory implementation and technical documentation support.
ISO13485 Quality Systems
Implementation and optimization of QMS processes.
Cybersecurity
Secure-by-design healthcare software and infrastructure.
AI in Medical Devices
Validation strategies for AI-enabled medical software.
Data Privacy
GDPR, data governance based on Need-To-Know principle.
Industries
The consultancy partner for qualified medical software, information and data analysis systems.
Specialized expertise in regulated MedTech
Supporting startups, scale-ups and established medical device manufacturers across Europe.
Why Medinex
✔ Deep regulatory expertise
✔ Engineering + compliance combined
✔ Security-first approach
✔ Practical implementation support
✔ European MedTech focus
Trusted standards & frameworks
Build on the standards your auditors expect.
Need support with regulated medical software?
Request a consultation to discuss ISO13485, IEC62304, information security or quality system implementation.
Request a meeting