ISO 14971:2019 Risk Management for Medical Devices

This Certification talks about risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices.

It assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

It is applicable to all phases of the life cycle of a medical device.

It covers risks associated with a medical device related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.

In the medical device industry, 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.

What are the benefits of ISO 14971?

1. Implement ideal methods of reducing risk for all stakeholders

2. Develop devices and therapies that are proven effective in the industry

3. Manage speed and cost to market

4. Optimize speed of iteration

5. Streamline the regulatory process that will enable entry to selected markets

6. 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.