Medical Devices: * Diagnostic short term and long term monitoring devices * Disposable and re-usable devices * DNA based diagnostic tests * ELISA based diagnostic tests * EO and Gamma sterilized medical devices * Gastroenterology devices * Implantable long term catheters * Implantable bone structure devices * IVD devices * Medical lasers for surgery applications * Optical medical devices * Software controlled devices and applications * Surgical devices QA & RA * FDA Quality System Regulation (QSR) - 21 CFR 820 * ISO 13485:2016 and ISO 9001:2015 * Canadian Medical Device Regulations (CMDR) * Internal auditing for compliance and improvement * Risk Management ISO 14971 * Corrective Action and Preventive Action (CAPA) systems * Process validation and design controls * Training of quality system applications and standards * Statistical techniques and analysis tools * 510(k) applications for medical devices * Technical Documentation