Regulatory Compliance Training

Build a quality-driven culture with regulatory training

Train with industry practitioners so your team embeds regulatory excellence into daily operations to accelerate approvals, avoid costly mistakes and get innovations to market faster.

Pick your training

Designed for creators that want to launch compliant innovations faster

Find regulatory training that fits your operational reality

The regulations you follow, the industry you compete in, and the way your team operates – all shape your compliance approach. That’s why our programs are designed to align with your market, technology, and internal workflows — giving your team the right knowledge at the right time to accelerate approvals and avoid costly missteps.

For custom requests, talk to experts

Machine Learning and Artificial Intelligence

Medical Devices and In Vitro Diagnostic Medical Devices

Information Security and Data Protection

Cross-industry

Automotive & Mobility

Meet our trainers

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Antonina Burlachenko
- Head of Quality and Regulatory Consulting
Antonina is the Head of Quality and Regulatory Consulting at Star, with expertise in medical device regulations, software and AI development lifecycle, quality assurance, project management, and product management. She is a certified lead auditor for ISO 13485 and ISO 27001 and supports our clients in regulatory strategy definition, quality, AI and information security management systems implementation and certification.
Recent posts by Antonina:
- How to address AI bias in healthcare
Maskym Tsivyna
- Information Security Manager
Maksym is a seasoned engineering professional with over 13 years of experience in information security, regulatory consulting, quality assurance and automation. As an Information Security Manager, he specializes in implementing robust security frameworks, such as ISO 27001 and SOC-2, and developing policies to safeguard information assets. He leverages his deep expertise to advise organizations on establishing AI Management Systems (AIMS) aligned with ISO 42001, helping them navigate technical controls and manage AI-specific risks effectively. Maksym excels in leading cross-functional teams, implementing information and data privacy management systems, and ensuring adherence to global compliance standards.
Recent posts by Maksym:
- ISO 27001 certification: Security assurance during software development
Pavlo Katolyk
- Quality and Regulatory Affairs Manager
Pavlo has over 10 years of experience in quality and process management across various industries, including the medical and automotive sectors.
He has led the development, verification, and validation of critical medical devices, including cardiopulmonary bypass (CPB) devices, computer-assisted surgical systems for minimally invasive therapy, and modular aesthetic laser multi-application platforms. His expertise covers QMS administration, compliance with ISO 13485, IEC 62304, ISO 14971, FDA regulations, and MDR, as well as requirements management, SIL/HIL verification, and gap analysis.
Pavlo also has extensive experience in audit management and a strong background in cybersecurity and data privacy for medical devices.

Our clients say...

We engaged Star’s regulatory consultancy services for targeted training on EU AI regulations. Their consultative approach during the preparation phase was tailored to our specific product context and for our key team members who needed to be equipped to navigate the new regulatory landscape confidently. I would highly recommend Antonina Burlachenko and the team at Star for their deep expertise in the EU AI Act, medical device software requirements, and practical experience in medical software engineering.

Thrilled to share that I’ve earned a new certificate in AI Literacy and Compliance Training! Grateful to Antonina Burlachenko and the team at Star for delivering such insightful and technical training sessions. The knowledge gained will be invaluable moving forward!

We meet you where you are. Literally.

Compliance training should fit your team’s reality, schedule, and learning style. Whether you need flexible online sessions or high-impact onsite training, we ensure your team gets the knowledge they need — when and where it matters most.