Creating safe and secure, user friendly health apps and medical device software
Are you aware of the methodologies available to identify and manage risk associated with your software? Is your software product compliant with the recent usability and effectiveness guidelines laid out in the Medical Device Regulation (MDR)?
Health software qualifying as a medical device must comply with the general safety and performance requirements (GSPR) pertaining to safety and security. In addition, under the MDR, developers must demonstrate compliance with development guidelines (such as IEC 62304 & IEC62366) ensuring user-friendly and effective devices. Using practical examples, this 6-module course teaches you bes tpractices to apply EU safety and security regulations ensuring your device is fully compliant. You will also learn various testing and evaluation strategies outlined in the MDR to create apps and software that meet usability and effectiveness requirements.
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 compliant with the evolving MDR.
Suitability - Who should attend?
This course is a suitable follow on for attendees from ‘Navigating the Regulations’ online course and is also suitable for professionals who work in software development who wish to further their understanding of how to apply the EU regulations to their product. Popular areas include:
- Regulatory Affairs
- Quality control
- Software Development
- Software Engineering
- Clinical Evaluators
- Post-market vigilance
Outcome / Qualification etc.
- Understand the importance of cybersecurity for health apps by learning about the key principles of data integrity
- Learn to minimise safety and security risks by applying methodologies detailed under GSPR
- Understand key risk management strategies to adequately identify safety and security risks associated with your software
- Develop your project management techniques to maximise the efficiency of your daily processes
- 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
Training Course Content
- Module 1: General safety and performance requirements and its technical documentation
- Module 2: Safety risk management: creating, implementing and using safe health software
- Module 3: Cybersecurity risk management: creating, implementing and using secure health software
- Module 4: Controlled design of health software
- Module 5: Creating user-friendly software
- Module 6: Clinical evaluation, post-market surveillance and vigilance
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
85% had applied content during the course to their role
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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