Medical Equipment Risk Classification

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 and...

Overview of Medical Device Classification and …

https://www.fda.gov/about-fda/cdrh-transparency/overview-medical-device-classification-and-reclassification

The FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their risks and the regulatory controls necessary to provide a reasonable assurance of …

Understanding Risk Classification of Medical Devices: 3 Major ... - Qualio

https://www.qualio.com/blog/risk-classification-of-medical-devices

Risk Classification of Medical Devices - Medsafe

https://www.medsafe.govt.nz/regulatory/devicesnew/3-7RiskClassification.asp

Rules of risk classification. Determining the risk classification is a simple process of working with Schedule 2 of the Medicines (Database of Medical Devices) …