TESTING & CERTIFICATION SERVICES for MEDICAL DEVICES
Construction, Engineering
Information
TESTING & CERTIFICATION SERVICES
for MEDICAL DEVICES
We test, inspect, and certify your active medical devices in accordance with European and global requirements.
OUR SERVICES
- Notified Body for the Medical Device Regulation (EU) 2017/745
- Notified Body for the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746
- Quality Management System Certification (ISO 13485)
- Product Safety (e.g. IEC 61010-X IEC 60601-X, ISO 14708-X)
- Electromagnetic Compatibility (IEC 60601-1-2)
- Environmental Simulation (IPXX / Transport Testing / HASS/HALT)
- Biocompatibility (IEC 10993)
- Radio / Wireless (RED, FCC), Telemedicine
- RoHS, REACH
- Software (IEC 62304)
- Functional Safety (IEC 61508)
- Usability (IEC 62366-1)
- International Certifications (e.g. North America, Brazil INMETRO)
- Green Mark Certifications (CO2 Footprint, Sustainability)
- Cybersecurity (e.g. IEC 60601-4-5, IEC 81001-5-1, Penetration Testing)
- Inspections
WE ARE SGS – THE WORLD’S LEADING TESTING, INSPECTION AND CERTIFICATION COMPANY
www.sgs-cqe.de
