Quality Assured
Our goal is to meet and exceed the most stringent quality standards in the world.
This assures that the provisions for your application will be met.
- FDA-Registered Facility
- AAMI(EC-13, EC-53, EC-38)
- CE-MARK – Medical Device Directive
- IEC 60601
- FDA 21 CFR820
- FDA 510K Approved Products
- ANSI/AAMI EC-53-1995 Cable and Lead Standards
- J-Standard
- Din 42-802
- All of the products represented in this catalog are produced under a
Quality Management System certified to ISO 13485.
If you have any additional questions about our quality assurance systems, please
feel free to contact us.
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