Quality Management Standard for Medical Devices
ISO 13485: 2016, U.L. Registered Firm, File Number: 10008175 MP2016
TriContinent meets the stringent and encompassing requirements for ISO Certification for the design and manufacture of Medical Devices. Requirements govern systems, planning, management, resources, product realization, and quality control procedures.
Click here to download TriContinent's current ISO Certificate
The RoHS (Restriction of Hazardous Substances) directive restricts the use of certain hazardous substances commonly used in the manufacturing of electronic equipment and requires producers of electronic equipment to reduce the concentration of these hazardous materials to the following acceptable levels by weight:
- Lead (Pb) < 0.1%
- Mercury (Hg) < 0.1%
- Cadmium (Cd) < 0.01%
- Hexavalent Chromium (CrVI) < 0.1%
- Polybrominated Biphenyls (PBB) < 0.1%
- Polybrominated Diphenyl Esters (PBDE) < 0.1%
At Tri-Continent we recognize our responsibility as a supplier of electromechanical assemblies and components used within electrical and electronic based systems and products that will be RoHS compliant. We are fully committed to offering RoHS compliance on our products. We have started a comprehensive evaluation and analysis program both internally and with our suppliers to establish and publish RoHS compliant statements for our products.
Many of our products are currently compliant. All new products are engineered to the RoHS directive and will be compliant.
Please contact email@example.com to find out if a specific product is RoHS compliant.
Food & Drug Certification
- Food & Drug Administration Registered Manufacturer, registration: # 2937957
- State of California, Dept. of Public Health, Food & Drug Branch, License # 62541