I help companies that make Medical Device with their Quality Management Systems (QMS) implementation and maintenance.* I establish and maintain QMS* I provide quality and regulatory oversight for software development, testing and release activities, including leading Product development Risk Management (ISO14971). * I audit QMS (internal and external), design and device history documentation for compliance with SOP’s, FDA part 820 QMS regulations and ISO 13485 standards. * I have experience in Software validation, following various Software Life Cycle methodologies such as waterfall, GAMP and Agile SCRUM, for manufacturing operations, automated processes and software medical devices.