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Medical Devices
The extended Law on Medical Devices developed by the European Union (EU) regulates the free movement of medical devices in all EC countries. It covers the medical products from the design, manufacture to marketing, thus ensuring safe applications and user-friendliness.
Our Service Scope
Quality Management System Certification
Non-regulated Area Standards :
- ISO 9001series
- ISO 13485/8
Regulated Area European Directive
- 90/385/EEC Active Implantable Medical Device Directive
- 93/42/EEC Medical Device Directive
- 98/79/EC In Vitro Diagnostic Device Directive
Product Safety Evaluation
- Electrical
- Mechanical
- EMC
- Microbiology and sterilization
- Biocompatibility Biological
- Chemical
- Physicial
- Manufacturing & environmental effective
- Measuring Function
- Specificity/Sensitivity/Stability
- Products specific requirements
Safety Standard Compliance Testing
- IEC 60601series Electrical test
- ISO 10993 series Biocompatibility Test
- EMC test
- List A Products batch release test
- On-site witness test
- Others, client specification
We offer product safety certificates & reports:
- Design examination certificate
- EC Type examination certificate
- C.O.C.
- GM mark
- T-mark
- cTUVus mark
- CB report
Other:
- International approval
- FDA Third party reviewer
- CMDCAS
- Initial design support and analysis
- Regulation explanation
