Janet Book

Janet Book works for NSF, one of the world’s leading consulting and service companies in medical technology. She has more than 35 years of experience in quality management systems, auditing and training for medical devices.

Prior to joining NSF, Janet worked in a wide variety of industries, including blood banking, food processing, quality consulting, chemicals, pharmaceuticals and medical devices.

She has conducted internal and supplier audits using many different industry-specific standards and regulations, including for the aviation, automotive, pharmaceutical, medical device, blood-banking and food industries. She has conducted due diligence evaluations as well as capability assessments, and has been involved with writing quality procedures, developing supplier and internal/corporate audit programs, developing quality management systems, and developing and presenting quality-related training and seminars.

Recently, Janet earned her Certificate in Privacy Law and Cybersecurity and worked in the world of privacy by providing guidance on quality, regulatory and compliance functions.

She has broad expertise in U.S., EU and other global regulations, as well as extensive training expertise in the fields of auditing, CAPA and root cause analysis.

Janet is a speaker at conferences and conducts training and workshops for medical device companies. She holds a Master of Business Administration from Phoenix University, a Bachelor of Arts in biology from Wittenberg University, and a Graduate Certificate in Privacy Law and Cybersecurity.

Areas of Expertise

• Global Medical Device Regulations
• Quality Management Systems
• Audits and Inspections
• Training Instructor
• Speaker at Conferences