Vital Kavalenka

With more than 29 years of experience in tech, Vital possesses a rare combination of software engineering proficiency and regulatory expertise in healthcare and financial sectors. Before joining ScienceSoft, he worked as a software developer, building mission-critical BFSI software, such as core banking, card processing, and loan processing systems. Vital also held department head roles, where he gained experience managing complex IT projects across regulated industries.

Since joining ScienceSoft in 2016, Vital has been instrumental in aligning the company’s internal processes with a number of regulations. Under his leadership, ScienceSoft became ISO 13485:2016 and ISO 9001:2015-certified and achieved compliance with ISO 14971, IEC 62304, and FDA 21 CFR Part 820. These changes strengthened internal quality management and enabled ScienceSoft to successfully deliver companion software for medical devices in strict accordance with regulatory requirements. Building on this foundation, Vital developed and rolled out a unified requirements framework based on ISO 29148:2018 and the INCOSE requirements approach. It harmonizes GDPR, HIPAA, HITECH, MDR, PCI DSS, and PCI SSF into reusable control sets and traceability checklists used across ScienceSoft’s client projects and internal QMS.

As a Compliance Officer, Vital also actively develops corporate compliance guides and conducts internal audits, ensuring company-wide adherence to evolving regulatory requirements and certification frameworks. In the domain of information security and privacy, under Vital’s leadership, ScienceSoft became ISO/IEC 27001:2022 and ISO/IEC 27701:2019-certified.

Beyond internal governance, Vital helps ScienceSoft’s clients establish and refine their compliance management processes, prepare technical documentation, and pass regulatory submissions. One notable example is his contribution to the development of laboratory diagnostics software, where he guided the project through a demanding compliance landscape. The solution had to meet multiple medical device software standards and required extensive submission documentation for regulatory approval.

Committed to knowledge sharing and continuous learning, Vital regularly contributes to ScienceSoft’s blog, where he shares insights on compliance frameworks, regulatory aspects of medical device software, and industry-specific IT trends. His work supports ScienceSoft’s clients in building compliant, trustworthy solutions that can stand up to rigorous audits and market scrutiny.

I believe compliance should be woven into the project’s DNA from day one, both at the level of business requirements and within the software development lifecycle itself. This way, compliance and security become natural properties of the software, not costly add-ons at the final stage.