Risk Management

The medical device risk management procedure mainly follows the framework specified by ISO 14971. However, there are specific standards for special areas, e.g., software, usability, and biological evaluation. In some countries, the special requirements also include the review guidelines of special devices. Manufacturers of medical devices can meet corresponding regulatory requirements through establishing a risk management procedure that conforms to ISO 14971 and/or specific standards.

Our Services:

Establish a risk management procedure

Plan the risk management process

Identify risks

Analyze risks

Identify risk control measures

Complete risk management files