Dessi Lyakov

Dessi Lyakov, as the Director of Quality and Regulatory Affairs at CliniComp, Intl., brings over two decades of comprehensive expertise in the medical device and IVD manufacturing sectors. In his current role, Dessi spearheads the development and execution of robust regulatory strategies that facilitate timely product clearance with the FDA, including successful 510(k) submissions and CE marking processes. His deep understanding of design control, validation protocols, and risk management ensures that CliniComp's innovative healthcare solutions meet the highest standards of safety, efficacy, and compliance. Dessi's leadership extends to overseeing internal and external audits—such as ISO audits and supplier assessments—while managing critical regulatory documentation and compliance activities. He plays a pivotal role in preparing the organization for FDA inspections, ensuring adherence to GMP and Quality System regulations, and maintaining a proactive approach to CAPA and complaint management.

Beyond his technical expertise, Dessi is a dedicated coach and mentor, fostering a culture of accountability and continuous improvement within his team. He emphasizes clear cross-functional communication, empowering his colleagues to make informed decisions aligned with regulatory requirements. His strategic insights and hands-on experience in quality assurance, design control, and UDI implementation have been instrumental in streamlining processes and enhancing CliniComp’s regulatory readiness. With a focus on integrating industry best practices and evolving regulatory landscapes, Dessi Lyakov continues to drive CliniComp’s mission to deliver safe, compliant, and innovative medical devices that improve patient outcomes worldwide.