Angela Kiser
Senior Quality and Regulatory Consultant
Background
Angela is an independent consultant who has worked in the medical device industry for over 15 years.
She is an ASQC Certified Quality Auditor, a certified EU MDR Auditor, and a certified ISO 13485:2016 Lead Auditor. Angela is proficient with clinical and hospital laboratory quality systems, including accreditation requirements, clinical trial management, and good clinical practice.
Her expertise also includes 21CFR 820 requirements, including medical device software, design history file documentation, and verification/validation procedures. Her broad background includes the EU General Data Protection Regulation and the Medical Device Single Audit Program. Angela is an experienced trainer and provides excellent customer service.
Education
Angela has a BA in Biology from Concordia University and an MBA from the University of Phoenix. Certified ISO 13485:2016 Lead Auditor, MDSAP Auditor, and EU MDR Auditor.