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Applying The Regulations: Creating Safe & Secure Health Apps & Medical Device Software

Course summary
3 weeks
420 GBP excl. VAT
e-learning / Online / Distance

Course description

Are you aware of the methodologies available to identify and manage risk associated with your software?

Health software qualifying as a medical device must comply with the general safety and performance requirements (GSPR) pertaining to safety and security. Intended as a follow-on from ‘Navigating the Regulations’, this course teaches you best-practices to apply EU safety and security regulations ensuring your device is compliant, maximising user safety and security. By means of industry expertise and practical examples, this course outlines methodologies such as Hazard and Operability Analysis (HAZOP) and Failure Modes Effects Analysis (FMEA) to adequately identify and manage risks associated with security and safety ensuring the design of safe and secure health software.

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

Training Course Content

  • 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

About provider

PTI - Pharmaceutical Training International

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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