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Classify Your Medical Device | FDA
- https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
- The three classes and the requirements which apply to them are: Device Class and Regulatory Controls 1. Class I General Controls With Exemptions Without Exemptions 2. Class II General Controls...
Medical devices - World Health Organization
- https://www.who.int/health-topics/medical-devices
- Today, there are an estimated 2 million different kinds of medical devices on the world market, categorized into more than 7000 generic devices groups. A medical …
Defining the Expected Service Life of a Medical …
- https://www.andrews-cooper.com/ac-insights/defining-the-expected-service-life-of-a-medical-device/
- Understanding the Standard for Expected Service Life Though medical devices are designed to ISO standards, expected service life is actually defined by IEC 60601-1 as “the time period specified by …
Medical Device Field Service: Service Level Agreements (SLA)
- https://info.bhnco.com/blog/medical-devices-service-level-agreements-sla-for-field-service-outsourcing
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