Risk Analysis Studies for Medical Devices

The Competent Authorities for the marketing of medical devicesrecognize that the basic rules of risk management must be applied to identify and address safety issues of medical devices throughout their entire life cycle.

The ISO 14971, is now officially recognized as the most appropriate risk management standard by all the Competent Authorities in the EU, USA, Canada, Russia, Australia and elsewhere.

The ISO 14971 improves an organization's ability to reduce uncertainty and to achieve the safety and the and effectiveness of medical devices when combined with a quality management system.

What NOVITAS for you:

• To integrate ISO 14971 into an existing quality management system.
• To carry out the process of identifying, estimating and and evaluating the potential risks associated with the medical devices produced or the services provided (distribution, technical support, etc.).
• To help you with establishing control points for reducing risks to acceptable levels and re-assessing them
• To guide you in defining the acceptance criteria for risks and in creating a system for collecting and reviewing production and post-market information.
• The effective monitoring of the performance of your medical devices, so that they produce the desired result, which is Patient Safety.