Health Software Development Lifecycle: From Concept to Compliance
Navigating the Complexities of Developing Safe, Compliant, and Innovative Health Software
Developing healthcare and medical software is a highly regulated and intricate process. From initial concept to deployment and post-market maintenance, ensuring safety, regulatory compliance, and seamless integration is crucial. The Health Software Development Lifecycle (HSDLC) defines best practices for software engineering, risk management, usability, cybersecurity, and regulatory adherence in healthcare applications.
At Health SDLC, we provide expert insights, step-by-step guidance, and industry best practices to help professionals navigate the unique challenges of health software development.
What We Cover
- Health Software Development Phases: Explore methodologies like Agile, Waterfall, and hybrid models to optimise the design, development, and validation of health software.
- Regulatory & Compliance Frameworks: Stay updated on FDA Software as a Medical Device (SaMD), IEC 62304, ISO 13485, EU MDR, IVDR, HIPAA, and GDPR for health software compliance.
- Risk Management & Cybersecurity in Health Software: Learn how to implement ISO 14971 risk management practices, secure software architectures, and vulnerability mitigation strategies.
- Software Validation, Verification & Testing: Gain insights into software validation strategies, usability testing, and continuous testing in compliance with global standards.
- Post-Market Surveillance & Software Maintenance: Understand change management, software updates, and ongoing risk assessment for regulatory compliance and system security.