The latest version of ISO 13485 quality management systems for medical devices has major additions to ensure products are safe for their intended use. These include regulatory harmonisation and a greater emphasis on risk management. The FDA also announced plans to harmonise their quality system regulations under the Medical Device Single Audit Programme (MDSAP) with ISO 13485:2016.
It is important for medical device and IVD quality professionals to stay up-to-date with the latest requirements. It is also important for you to have the skills to apply the standard to your products. We provide ISO 13485 quality training, so you have the skills to confidently optimise your quality strategies and processes. Whether you are new to quality or experienced, our courses can support you develop and grow in this field. For leaders, we also deliver strategic ISO 13485 quality management training so you have the knowledge to develop and implement a successful QMS. We also offer online ISO 13485 courses so you can train anytime and anyplace with ease.
We provide both online and classroom training courses to support medical device and IVD quality professionals. All courses are carefully designed to improve your regulatory performance back in the workplace. Our longer online and classroom courses include post learning support to help you apply your skills back in the workplace. Our courses are designed to help you understand and apply the latest quality standards and requirements to your IVD and device products.
Find a quality course relevant for you below. Click on a course you are interested in to learn more about the agenda, delivery format, trainer and price. If you would like to join the course you must enrol and pay through the website. If you have any questions, please message us on live chat (bottom right).
We support leaders working in quality management improve the technical skills and knowledge of their employees. This helps your team overcome challenges and meet business objectives. Working together, we design and deliver technical training courses that align with your learning requirements and business goals. For more information about how we can support your team please get in touch.
Could your regulatory or quality team benefit from any of the courses listed above? Or maybe a topic which is not highlighted? We would be happy to discuss your objectives and see how we might be able to help.