Derek Guan-Yu So is a quality engineering and assurance consultant with over ten years of experience in the medical device field, assisting manufacturers in the establishment and maintenance of quality, design control, and risk management systems. Mr. So takes a unique approach to setting up quality systems based on assessment of current company needs and product development stage, scaling the quality system for company growth and adapting the system as needed. His areas of expertise include establishing, assessing, improving, and maintaining quality management systems for conformity with FDA guidance and regulations including ISO 13485, ISO 14971, and 21 CFR 820; working with design control and risk management teams on design verification, validation, and process validation activities; executing investigative and CAPA functions; assisting manufacturers in establishing appropriate design, production, safety, and supplier controls in preparation for manufacturing clinical use products; and providing technical writing expertise for generating quality records, procedures, and reports. Mr. So has served in prior Quality roles at Medtronic, Vertos Medical, LensGen, and ReVision Optics. He received his Bachelor of Science in Biomedical Engineering from UC Irvine.
Regulatory Pathways Group Inc.
a California corporation
Inquiries and general information:
info@regulatorypathways.com
