André Piccolomini, Ph.D.

• Lead the implementation and maintenance of the ISO 13485:2016 and associated infrastructure that is compliant, effective, efficient and agile; • Act as Tactio’s Quality Management go-to resource for the QMS and own the respective architecture and processes; • Establish, implement, document and maintain QMS to meet other types of certifications, i.e.; MDSAP, CE class IIa, ISO 9001 and other regulatory requirements as applicable; • Ensure the promotion and awareness of applicable regulatory requirements and quality management system requirements throughout the company; • Design and implement training programs on quality practices, including new hire quality orientation and compliance; • Design and execute efficient, effective internal audits and compliance monitoring programs, including conducting and overseeing auditing activities; • Act as the primary contact for customer quality requirements including audits, corrective actions, communications and engagement; • Report to top management on the effectiveness of the quality management system and coordinate and participate to create solutions, processes and alignment; • Identify, investigate and escalate areas of non-compliance, risk, and/or potential improvement and develop plans and propose solutions for appropriate action; • Coordinate a team of quality assurance representatives; • Ensure compliance with privacy legislation; • Apply for governmental grants for internship subsidy; • Conduct internal audit for the Information Security Management System, ISMS (ISO 27001:2022) in a yearly basis.

Instruct software developers to create new and innovative health-related apps for iOS and Android platforms. Give training to customers about the TactioRPM system, particularly RPM1000 and RPM6000.

Courses: Nutritional Assessment, Nutrition Through Life, Nutritional and Health, and Psychology.

Area of expertise: Stable isotopes to assess protein synthesis rate (L-[ring-2H5] phenylalanine), whey protein isolate pressurization, cell culture (Caco-2 cells), and animal studies (piglet colitis model). Laboratory techniques acquired: a) GC-MS, b) HPLC, c) ELISA, and d) in vitro assays (FRAP, DPPH, Folin-Ciocalteau, ROS, and MTS), e) protein extraction from tissues for SDS PAGE and Western Blots and enzymatic protein digestion for cell culture (whey protein isolate).