Monitoring of requirements
MAATEL maintains and develops its organisation as closely as possible with European and International standards.
Regulatory Aspects
The EN 60601‐1 Standard and its derivatives, are general requirements for basic safety and essential performance of electronic‐medical devices.
Standard EN 62304, medical device software, software life‐cycle process.
FDA 21CFR820 QUALITY SYSTEM REGULATION (QSR) Medical devices.
System
YOU can benefit from our experience, expertise and our advice in terms of development and manufacturing of electronic devices for your products regarding the requirements of ISO 9001 and ISO 13485 (Quality management system specifically for medical devices).
