Capitalise on the opportunities of medical device software under the EU MDR and accelerate your market success
Gain an understanding of the key pillars including classification, cybersecurity, digital health, clinical evaluations and PMS
Course Overview
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.
What will you learn?
EU regulatory framework
Gain a comprehensive overview of the EU regulatory framework for software products
Requirements
Understand the safety and performance requirements imposed by law on medical device manufacturers
Key processes
Become equipped with a working knowledge of the processes needed to make safe, secure, reliable and effective software
Dossier development
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
Live Online Training Course
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment.
Over 2 days students will learn through:
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including case studies, Q&A and interactive discussion
- 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 two days prior to the course start date. If you have any questions please contact filippo.scovasso@informa.com.
Who is this course for?
The course covers both software-only products, hardware products 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
