This compact workshop aimed to increase competence in the practical implementation of regulatory requirements. While promoting efficient software development, the workshop provided for an introduction to quality assurance and approval of medical software (also: software-as-a-medical device or medical device software).
The workshop covered regulatory basics, process, documentation, SOUP, risk management and cyber security and put emphasis on IEC 62304 and ISO 14971 standards.
In the contribution by OSS Group, we took the audience through the Current Threat Landscape and highlighted the deficiencies that continue to persist in the IT sector, and in health, specifically. We covered Infrastructure Security and Security Posture. The workshop provided guidance on modern Identity and Authentication, with specific focus on FIDO2 password-less authentication. The presentation then took a deep dive on Security in Software Design, Software Lifecycle and Vulnerability Management as well as Cloud Native and Software Supply Chain Security.
OSS Group is delighted to have partnered with Callaghan Innovation, the University of Auckland’s Bioengineering Institute and Johner Institute Christchurch on this event.