Risk Management is an important but difficult concept for lots of industries, but is particularly important within the medical field and hence within medical devices. In such a hazard-rich industry, risk must be considered from the beginning to the very end of a product lifecycle. Implementing risk has never been more challenging, as recent regulatory changes have made it problematic to harmonize risk management processes in product lifecycles. Therefore, it is imperative to understand how to coordinate an effective risk management strategy.
This interactive course offers a comprehensive overview of the regulatory requirements for risk management and provides an insight into a variety of tools and techniques to implement them into your own systems. Attendees will be provided with an in-depth outlook on ISO 14971:2019 and its overlap with ISO 13485:2016 and the new MDR, alongside gaining an informed insight into the intricacies of risk management planning. Overall, attendees will expect to be taken through the risk management process from start to finish.
Attendees will be able to cement this knowledge through case studies and practical exercises, with additional time on the course provided to discuss the implications of Brexit.
Live Online Academies
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses.
Students will learn through:
- Live interactive sessions
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
- Revisiting recorded sessions with unlimited access for 30 days
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact firstname.lastname@example.org.
What will you learn?
Risk management under the MDR
Update your knowledge of the risk requirements in the new MDR
Key regulatory standards
Gain a comprehensive overview of the global regulatory standards for risk management, including ISO 14971:2019, ISO 13485:2016, EN ISO 62366-1 and critically referenced standards such as EN ISO 10993-1 and ISO 14644
Risk management techniques
Develop your skills in risk management planning by practically applying a variety of tools and techniques to case studies
Analysis of risk management activities
Learn how to effectively analyse ongoing risk management activities such as PMS and clinical investigations and enhance your understanding of their regulatory procedures
Cement your knowledge through group discussions, case studies and interactive exercises
Who is this course for?
This course will be useful for personnel involved in risk assessment and risk management activities, and for those who need a complete in-depth overview of the medical device regulatory framework for risk management throughout the entire device lifecycle. It will be applicable for professionals in:
- Regulatory affairs
- Quality assurance
- Product managers
- Design engineers
- Clinical staff
- Project managers
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.
Delegates of our live online academies said...
would attend another live online academy
found the course beneficial to their day to day role
would recommend the course to others
25% discount on Routledge books
As a student on the course you will receive a 25% discount on any Routledge books or eBooks. To view the full product range visit the Routledge website www.routledge.com.
Examples of books and eBooks within medical devices include:
- ISO 13485:2016: A Complete Guide to Quality Management in the Medical Device Industry, Second Edition
- ISO 9001: 2015 - A Complete Guide to Quality Management Systems
- Medical Device Quality Assurance and Regulatory Compliance
- Design Controls for the Medical Device Industry, Third Edition
- And more