Published on Jan 21, 2025
In the ever-evolving medical device industry, risk management is more than a regulatory requirement. The industry is founded on trust between those who design, develop, and manufacture devices, and those who depend on these devices to work safely and effectively.
Risk Management can be confusing, and many medical device organisations struggle effective risk strategies. Failure to adequately address risks can lead to a variety of problems, including regulatory non-compliance, compromised patient safety, and financial setbacks. Thankfully, ISO 14971 is useful in providing risk management guidance and direction.
Understanding ISO 14971:2019, the international standard for medical device risk management, offers numerous benefits for professionals across various roles within the industry. Here’s why you should consider enhancing your knowledge in this area.
ISO 14971 provides a comprehensive framework for identifying, evaluating, and controlling risks associated with medical devices. This standard is essential for:
The principles of ISO 14971 aren’t just theoretical—they have practical applications that can significantly benefit your daily work. By understanding this standard, you can:
In a field like medical devices where effective risk management is crucial, understanding and implementing ISO 14971 is invaluable. Whether you’re a regulatory specialist, R&D scientist, QA team member, or part of the clinical support team, this knowledge can significantly benefit your career and your organisation.
Invest in your professional development and join the ‘Introduction to Risk Management ISO14971:2019’ course to stay ahead in the industry. By joining the course you will also gain insights into risk management planning, roles and responsibilities, risk control measures, and documentation and record keeping.
Published on Jan 21, 2025 by Jasmin Cheklam-Smith