How can regulatory affairs professionals add value and efficiency into regulatory compliance practices in medical device development projects?
2020 marks an important date for the Medical Devices industry, as the European Union’s Medical Device Regulation (MDR) will take effect. Two years after, the In-Vitro Diagnostic Medical Devices (IVDD) will follow. These regulations are set to constitute major changes for the industry, and these changes bring a high degree of uncertainty with them. Among these changes and the ever-increasing intelligence of health tech solutions, it is more important than before to adopt modern business thinking into regulatory affairs.
This essential course will provide you with an effective and informative outlook on the regulatory essentials and project management methodologies used in regulatory affairs for medical devices. During the course, delegates will gain a solid understanding of the core ingredients needed for successful projects, and learn how to coordinate key regulatory requirements for medical devices throughout project management. In addition, this course provides an insight into the future challenges for medical devices and offers solutions to tackle them.
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, delivered in bitesize sessions of 1.5-3 hours online.
Over 1-week students will learn through:
- Live interactive bitesize 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?
An introduction to project management
Applying regulatory requirements to project management
Managing regulatory changes and communicating with authorities
A closer look at clinical evaluation in a project
Applying risk management in a project
Managing project cycles
This course is complemented with group exercises and a case study to apply course content to a practical situation
Who is this course for?
This course is ideal for professionals with a minimum of 3 - 5 years' experience or those who are junior to mid-level regulatory affairs professionals in the medical devices industry.
Additionally, both experienced project managers and project managers looking to apply their knowledge in the medical device industry would benefit, as this course focuses on managerial and leadership development - alongside new Medical Device Regulation (MDR).
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...
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:
- Medical Device Quality Assurance and Regulatory Compliance
- Medical Instruments and Devices: Principles and Practices
- Medical Device Packaging Handbook, Third Edition
- Medical Device Regulatory Practices: An International Perspective
- And more