ServiceUpdated on 30 October 2025
Medical Software Diagnosis
CEO at EFF'INNOV Technologies
Colombelles, France
About
The standard EN 62304 establishes requirements for the lifecycle of medical software.
It covers specification, design, validation, and maintenance, with a focus on risk management.
As a harmonized standard, it enables the demonstration of egulatory compliance for medical software within the EU.
Thorough technical documentation helps secure the acquisition of the CE marking.
Attached files
Similar opportunities
Service
- Certification
- INTELLECTUAL PROPERTY, LEGAL AND FINANCIAL SERVICES
Barend Smet
President and Co-Founder at Thaumatec Tech Group
Wroclaw, Poland
Expertise
Medical Compliance & Quality Assurance
- E-HEALTH
- INTELLECTUAL PROPERTY, LEGAL AND FINANCIAL SERVICES
Barend Smet
President and Co-Founder at Thaumatec Tech Group
Wroclaw, Poland
Product
Patient Monitoring Firmware & Cloud Software Platform
Barend Smet
President and Co-Founder at Thaumatec Tech Group
Wroclaw, Poland