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Is your software product compliant with the recent usability and effectiveness guidelines laid out in the Medical Device Regulations (MDR)?
Under the MDR, developers must ensure their software comes under the classification of a medical device, then demonstrate compliance with development guidelines (such as IEC 62304 & IEC62366) ensuring user-friendly and effective devices. In this course you will learn about the different testing and evaluation strategies outlined in the MDR to create apps and software that meets usability and effectiveness requirements. In addition, you will learn about the importance of conducting robust clinical investigations, evaluations and post-market vigilance reporting.
If you are involved in the development of health software, or responsible for regulatory or developmental control, then this course details everything you need to know to ensure you are remaining compliant with the evolving MDR.
Suitability - Who should attend?
This course is recommended for professionals in software development who wish to further their understanding of how to apply the EU regulations to their product. Popular job areas include:
- Software Developers and Engineers
- Regulatory Affairs
- Quality Control Managers
- Clinical Evaluations
- Software Engineering
- Quality Assurance & Control
Training Course Content
- Build-on your knowledge of the International Standards relating to the usability of your software device.
- Discover key considerations for clinical investigations, evaluations and post-market activities for your device
- Apply a range of different software platforms, plugins and design controls to your own health app or software
- Develop key project management techniques to effectively design your device
PTI - Pharmaceutical Training International - Training for the Pharma Industry
PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...
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