In the medical device industry, risk management goes beyond development and manufacturing; it is a vital part of all your organization’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.
Risk Management is one of the major requirements for a medical device. Our consultants work hand-in-hand with you and your team to develop strategic solutions that will address your specific needs. We provide support throughout your entire product development cycle to help you navigate the complexities of building a Risk Management File to incorporate risk analysis, hazard analysis, production/post-production device monitoring, and more.
In-depth review of your regulatory strategy and determine how this project aligns with your business objectives:
Evaluation of your current compliance to three major components:
We know how to help you identify the simplest, most effective approach to constructing your Risk Management File.