Risk management applied to Medical Devices (ISO 14971:2019)

Risk management goes beyond development and manufacturing; it is a vital part of all your company’s processes. ISO 14971 defines the international requirements of risk management systems for medical devices, defining best practices throughout the entire life cycle of a device.

To ensure your company gets a safe, effective product to market on time and within budget, you need a successful implementation of your risk management system.

With the newly updated ISO 14971:2019 standard, GMED North America has created a 2-day training session, to equip medical device manufacturers with the right understanding and implementation of the Risk Management for Medical Devices – ISO 14971:2019.

REQUIRED LEVEL

• General knowledge of Risk Management for Medical Devices principles
• Global knowledge of the European Medical device regulation: Directive 93/42/EEC and regulation (EU) 2017/745.