This course offers a practical understanding of the European regulatory requirements applicable to medical device software, including a detailed overview of the Medical Device Regulation. Whether your software is an app or a cloud computing service, whether it comprises firmware for integration in a medical device, artificial intelligence or an application for the Internet of Things, you will learn whether the regulation applies to it and how to classify it.
Live Online Academies
Gain real-time access to two subject matter experts 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.
Over this live online course students will learn through:
- 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
- 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?
EU regulatory framework
Gain a comprehensive overview of the EU regulatory framework for software products
Understand the safety and performance requirements imposed by law on medical device manufacturers
Become equipped with a working knowledge of the processes needed to make safe, secure, reliable and effective software
Learn what evidence to collect and how to compile a technical file and clinical evaluation report
Risks to security
Critically analyze how neural networks, machine learning and autonomous systems challenge classical safety processes and principles
Who is this course for?
The course covers both software-only products, hardware product with embedded software, health apps and medical device software and is suitable for professionals in the following roles:
- Project and Product Management
- Software Architects
- Designers and Developers
- Research & Development Management
- Requirements Engineers
- Verification, Validation and Clinical Evaluation Specialists
- Usability Experts
- Cybersecurity Experts
- Risk Management Moderators
- Quality and Regulatory Specialists
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.