How to identify and analyze risk control options and implement those risk control measures that reduce risk as far as possible, without adversely affecting the benefit-risk ratio.
ISO 13485: The Global Quality Management Systems Standard for Medical Devices
With the explosion of medical devices and manufacturers, a need was realized to develop a medical-device-specific standard based on ISO 9001. The result is ISO 13485.
Medical Device Regulations Part 1 — USA
Since 1906, the US FDA has sought to ensure the safety and efficacy of medical devices. This article outlines the history and rationale that created the Quality System Regulation for Medical Devices 21 CFR Parts 820.
Medical Device Regulations Part 2 — Europe
An introduction to The European Union Medical Device Regulation (EU MDR) 2017/745, CE certificates and the companion standard European Union Invitro Diagnostic Regulation (EU IVDR) 2017/746.
Brief History of Medical Devices and Regulations
Learn about that history of medical devices from ancient to modern times, and how regulations evolved in the mid-20th century to protect patients and ensure safe and effective medical devices.