Book Release: Software as a Medical Device
Are you a regulatory professional involved in the development or marketing of health software?
The Regulatory Affairs Professionals Society (RAPS) have published an insightful guide to the complex landscape of regulations, state-of-the-art standards, and interpretations applications to health software, with a focus on software as a medical device.
Readers will be able to instantly apply the methodology in the book to assess business and product plans, identify possible roadblocks and pitfalls, avoid surprises during software development, regulatory submissions, and software distribution, and convince decision makers to grant your software a place into the care pathways.
Topic covered:
- Software as a Medical and IVD Medical Device
- Classification of Medical Device Software
- Clinical Evaluation of Software
- Safety Risk Management of Software
- Security Risk Management
- Software Development
- Open Source and Third-Party Software Components
- Software Usability Engineering
- Artificial Intelligence
- Quality and Reliability of Health Apps
- Regulatory Implications of Digital Distribution Models for Medical Device Software
- Market Access and Reimbursement of Digital Health Technologies
- Software Liability
The book was edited by Koen Cobbaert, who has delivered medical device software training courses at Management Forum since 2014. The chapters were written by world-leading software experts, including Zuzanna Kwade, another Management Forum lecturer specialising in clinical evaluations.
To order the book or download a sample chapter, please click here.
If you would like to hear from these industry leaders directly within an interactive training environment, the content of the book aligns well with one of our popular courses: Medical Device Software: Complying with the EU MDR & FDA Regulations, presented by Koen Cobbaert and Zuzanna Kwade.
Posted on May 31 2021 by Sophie Toms
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