Thomas Bento is a student of Quality and Regulatory Compliance and has been supporting the design, development and compliance of Medical Device Manufacturing for 17 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, Regulatory consulting and SVP at Nihon Kohden America. Now he is Consulting for Philips Medical Systems. Through his experience he has found that the common thread that runs through the fabric of most Medical Device Manufactures is that more is better in order to meet 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 founded on understanding and addressing Risk Management Appropriately.
When used as intended, process validation can provide increased process reliability, confidence, improved yields, and reduced operating expenses significantly. Compliance to 21 CFR Part 820.70(i) Automated Process is required for Medical Device Manufacturers FDA inspectors are now being trained...
This webinar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/ usability program. The ISO 62366 is an “Consensus” Standard, making it a gold standard for...