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
Software lifecycle management, IEC 62304 and SaMD.
Project Management
Managing multidisciplinary projects from concept to market.
Information Security
ISO27001 and NEN7510 implementation.
Risk Management
ISO14971, FMEA and usability engineering assistance.
MDR / IVDR Compliance
Regulatory support throughout the product lifecycle.
ISO13485 Quality Systems
Practical quality systems that scale.
Cybersecurity
Security throughout the development lifecycle.
AI in Medical Devices
AI governance and ISO 42001.
Data Privacy
GDPR and privacy-by-design.
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
Need support with regulated medical software?
Request a consultation to discuss ISO13485, IEC62304, information security or quality system implementation.
Request a meeting