Quality
Regulatory Compliance for Complete Confidence
As important as product functionality and service, one of the most important questions you can ask any medical device manufacturer is, “What steps have been taken to ensure the safety of your products?” ScottCare invests significant resources to verify its products are designed and produced to ensure patient safety in the U.S., Canada and the European Union. Don’t take our word for it. Extensive and unbiased, third-party testing and certification services verify that ScottCare’s products meet the requirements of internationally-recognized safety-based standards, including:
| IEC/EN 60601-1 | Medical Electrical Equipment General Requirements for Safety (International / European standard) |
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| UL60601-1 | Medical Electrical Equipment General Requirements for Safety (US National Standard) |
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| CAN/CSA-C22.2 | Medical Electrical Equipment General Requirements for Safety (Standard includes specifics of Canadian electrical code) |
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| IEC/EN 60601-1-2 | Electro Magnetic Compatibility for Medical Electrical Equipment (International / European standard) |
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| IEC/EN 60601-2-38 | Particular Requirements for the Safety of Electrically Operated Hospital Beds (International / European standard) |
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| 93/42/EEC | European Medical Device Directive (Compliance indicated by the “CE” mark) |
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| ISO 13485 | Represents the requirements for a comprehensive management system for the design and manufacture of medical devices |
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| CMDCAS | Canadian Medical Devices Conformity Assessment System program |