Development of Medical Device Quality Manuals
St. Cloud State Series
Registration: 7:30 am - 8:00 am
Program: 8:00 am - 9:30 am
First in a series produced in conjunction with St. Cloud State University's Twin Cities Graduate Center, home to applied Master of Science degree programs for the med-tech industry.
DEVELOPMENT OF MEDICAL DEVICE QUALITY MANUALS
A detailed overview of the intent, principles and approach in developing a quality manual in meeting FDA Quality System Regulations (QSRs), ISO-13485 and other international standards governing medical devices. This will include reviewing the primary sections and topics that are commonly included in the quality manual.
•Why is a quality manual required to meet QSRs and ISO-13485.
•How is a quality manual assessed during an external inspection by the •FDA and Notified Body.
•What are the common pitfalls when developing a quality manual.
•How to use the quality manual as the roadmap in explaining the company's quality system.
Steven B. C de Baca, CRV Vice President of Quality, Boston Scientific Corporation, CRM
Steven B. C de Baca Steve C de Baca is the VP of Quality at Boston Scientific Corporation responsible for over 1500 employees across the Quality (more)
The following topics will be addressed:
St. Cloud State University
Twin Cities Graduate Center
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