ISO 14971 Risk Analysis and Risk Management File Support for Medical Devices

ISO 14971 Risk Management is one of the major regulatory requirements for a medical device. The risk management in the medical device industrygoes beyond development and manufacturing of the device. Itis an integral part of your organization’s quality management system. The ISO 14971 defines the international requirements of risk management system andbest practices for the entire life cycle of a medical devices.

Our FDA 510(k) consultant can work together with you and your company to develop strategic solutions that will address the specific needs of your device. We provide support for the entire duration of the product development life cycle to help you navigate the complexities of building a Risk Management File (RMF) that incorporates risk analysis, hazard analysis, production, and post-production device monitoring, etc.,

Our FDA consultants perform an in-depth review of your regulatory strategy and determine how your device development and FDA approval plan aligns with your business objectives:

Our Risk Analysis and Management support process contains three major components:

• Risk Management Process
• Product & Process Risk Analysis
• Risk Management File

Our FDA 510(k) consultantsgot the required experience to help you identify the simplest, most effective approach to construct your Risk Management File.

Please contact us for further information about our Risk Management File Support services. We may be able to assist you to get your RMF work done in compliance with ISO 14971 standard.