Learn how to choose the optimal route to market your software under the Medical Device Regulation
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.
除了为期两天的,你也会在rolled onto an online module focused on cybersecurity, comprising of pre-recorded video lectures, quizzes and downloadable presentations.
What will you learn?
EU regulatory framework
EU regulatory framework
Gain a comprehensive overview of the EU regulatory framework for software products
Requirements
Requirements
Understand the safety and performance requirements imposed by law on medical device manufacturers
Key processes
Key processes
Become equipped with a working knowledge of the processes needed to make safe, secure, reliable and effective software
Dossier development
Dossier development
Learn what evidence to collect and how to compile a technical file and clinical evaluation report
Risks to security
Risks to security
Critically analyze how neural networks, machine learning, and autonomous systems challenge classical safety processes and principles
Case studies
Case studies
The course is complemented by case studies, practical sessions and quizzes
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
CPD Certified
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.
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 websitewww.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
- Usability Testing of Medical Devices
- Nanotechnology in Biology and Medicine: Methods, Devices, and Applications, Second Edition
- And more
