Thomas Bento is a student of Quality and Regulatory Compliance and has been supporting the design, development and compliance of Medical Device Manufacturing for close to 15 years. He started his career training in Software engineering and shortly moved into Commercial Software Quality. After many years of working for companies like Mitek Systems and Hewlett Packard, the decision was made to work in the regulated space of Medical Device Manufacturing, working at Edwards, Pulmonetic Systems and as a regulatory consultant for small, medium and large Medical device manufactures.
He is currently working as the Sr. Vice President of Quality & Regulatory Assurance at Nihon kohden America, manufacturers of Patient Monitors, Neurological and Cardiovascular devices.
Through his experience he has found that most Medical Device Manufactures feel that more is better to meeting regulatory expectations. He finds that this is the exact opposite and that manufacturers are better off by cultivating a simplified defensible approach to regulatory compliance.
This course will teach how to comply to 21 CFR Part 820.70(i) and effectively implement a software validation program for medical devices, meeting the FDA requirements and produce a safe product. We will explain the role of Risk Management in Non-Product Validation. How software requirements are used in validation will be described.
This webinar will explain the implementation of ISO 62366 and the regulatory expectations discussed.