Sabyasachi Roy MSEE, PhD

Sabyasachi Roy is experienced in medical device product development lifecycle from concept to design and development, launch and postmarket surveillance. Specialized in pre-market and post-market regulatory activities of medical devices using sophisticated sensor technologies, signal processing and software. Strong track record in developing and bringing to market artificial intelligence (AI), machine learning (ML) based medical devices that dominate head injury and concussion assessment. Experienced as Management Representative and responsibility of maintaining medical device design and development processes, quality assurance standards (ISO 13485, MDSAP). Managed relationship with regulatory entities such as FDA, Health Canada, notified bodies such as TUV, BSI, Intertek, and CRO such as Parexel. Excellent interpersonal skills to work effectively with internal team members as well as external partners and vendors. Strong combination of strategic thinking and day-to-day problem solving, acting decisively and ability to provide both strategic and operational guidance.