Medical device companies MUST have established risk management processes that comply with ISO 14971.
And it doesn't matter if you are developing medical devices in the U.S., EU, Canada, and so on.
EVERY INTERNATIONAL REGULATORY AGENCY YOU’VE EVER HEARD OF ACCEPTS ISO 14971
ISO 14971 is a good standard. Informative and descriptive. Easy (enough) to comprehend. AND THE RISK MANAGEMENT STANDARD FOR THE MEDICAL DEVICE INDUSTRY.
What does ISO 14971 require?
ISO 14971 helps your company establish, document, and maintain a systematic process to manage the risks associated with the use of a medical device. This includes ongoing monitoring of field experience, thereby embracing the concepts of continuous improvement and state of the art device performance. To maximize effectiveness of your risk management system, ISO 14971 can and should be an integral part of your quality management system (QMS) as required by ISO 13485.
Specific requirements of ISO 14971 include:
Provision of adequate resources
Assignment of qualified personnel
Establishment of a policy for risk acceptability criteria
Management reviews of the Risk Management System
Choose MAVEN as your consultants for medical device risk management as per ISO 14971
Our experts understand what it takes to connect and manage process interactions to produce the desired outcome: patient safety. MAVEN’s consultants can help you assess your quality system, implement ISO 14971, and comply with risk management requirements in markets around the world in a competent, cost-effective way. We can help to bridge the gap between the seemingly abstract risk management concepts and product design input and output requirements. We have extensive experience integrating ISO 14971 into existing ISO 13485 and FDA GMP QMSs, and team members participate in development of the ISO 14971 risk management standard.
Ask us about implementation and risk management consulting services for medical devices as per ISO 14971.