Medical Device Compliance Testing
Certify innovative medical devices for safe global use
F2 Labs certifies products such as tractors, plows, cultivators, planters, balers, harvesters, augers, sprayers, and autonomous ag-equipment, milking machines for global markets. Manufacturers rely on us as their proven testing partner to meet agricultural machinery compliance needs. From machinery safety, environmental performance to EMC and wireless approvals, we help you launch on time.
From hospital systems to home health and wearables, medical products face the world’s strictest compliance requirements. We help you get your product to market quickly.
Medical Testing Capabilities
- IEC 60601-1 safety and collateral/particular standards
- EMC testing for medical devices (IEC 60601-1-2)
- Risk management support aligned to ISO 14971
- Environmental & IP for clinical, home, and transport use
- Wireless/RF for connected care (Wi-Fi, BT, NFC, etc.)
Key Standards
- IEC 60601-1 / 60601-1-2 / 60601-2-x
- ISO 14971 risk management
- IEC 62366-1 usability (consulting support)
- FCC / ISED / CE RED / UKCA for wireless functions
How We Can Help
- FDA ASCA Summary Report for EMC and Electrical Safety
- Wireless coexistence issues in crowded hospital RF environments
- Common EM Emitters Testing
- Pre-testing and Preliminary Design Reviews
FAQ
Yes. We tailor evidence depth to your class and target region.
Yes, we provide test reports that are accepted by the FDA and EU.