Auriga, a custom software development services provider, participated in the European Medical Device Software Development and Compliance Virtual Conference in October 2021. Andrey Shastin, Auriga’s Head of Global Business Development in the medical and embedded systems domains, and Airat Sadykov, Senior Project Manager in medical systems, gave talks on implementing cost-effective test automation approaches to ensure SW quality & compliance.
The two main topics the conference focused on were Device Software Compliance and Medical Devices Cybersecurity. Andrey Shastin and Airat Sadykov contributed to the Device Software Compliance discussion by presenting Auriga’s vision of test management in medical software development. With particular attention to the testing strategy, the speakers demonstrated various approaches to test management concerning quality & compliance and cost issues. As part of the session, they tackled such critical points as a reasonable balance between manual and automated testing, benefits and drawbacks of custom simulator and robot usage, maximizing test and code coverage. The attendees showed high interest and offered up insightful questions exploring more details of test management. The video of the session is available on our website.
As part of the conference, Andrey Shastin moderated the roundtable on Barriers in Managing SaMD. The discussion touched upon such vital issues as:
- alignment between medical devices software classification and SaMD categorization,
- specific requirements for quality management systems to ensure SaMD compliance,
- SaMD cybersecurity requirements and data management,
- interoperability issues of SaMD and hospital health record management systems.
Andrey Shastin had the following to say on his participation in the conference:
“I enjoyed the conference, primarily because of the insightful sessions and thoughtful discussions we had with recognized professionals in the medical device software domain. Since Auriga has accumulated vast experience in this area over the years, we are happy to share our firm knowledge and help other companies enhance their services in such a highly regulated and risky industry as healthcare.
However, one of the main objectives of such conferences should be the further exploration and development of the topics raised at the meeting. We at Auriga hope to find ways to foster the connection created with other companies and pursue the discussion to draw out the necessary insights”.
Auriga boasts 18+ years of medical software development and testing experience, and it has repeatedly been acknowledged by both customers and industry experts, such as the IAOP®. The company is ISO 13485-certified and runs eight R&D and testing labs for medical devices in Eastern Europe. Explore our online portfolio of medical device and digital health projects, or contact us via the website to get more information on Auriga’s services.
