ISO 14971 defines the international requirements of risk management systems for medical devices, defining best practices throughout the entire life cycle of a device.
Garza MD is familiar with the requirements of this standard and can help you implement a risk management system.
Garza MD also developed a Training on Risk Management for (software) developers, designers and researchers.
ISO 9001:2015 defines requirements around risks and opportunities of your organization. In managing risks and opportunities you can steer your organization and get more control over uncertainties. Garza MD can help you to address these requirements.