This study provides insights into how medical device companies are mobilizing resources to support meeting quality standards and regulations throughout the product life cycle. This research establishes meaningful metrics around Quality cost and staffing as well as organizational structure for the function in the U.S. and globally.
Quality Staffing & Performance: Ensuring Quality and Safety While Managing Cost Effectiveness for Medical Device Companies
1. Benchmarking Quality Staffing & Performance:
How Medical Device & Technology Companies Ensure
Quality & Safety While Managing Cost Effectiveness
Best Practices, LLC Strategic Benchmarking Research
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2. TABLE OF CONTENTS
I. Research Objective & Methodology p. 3-15
II. Quality Organization Cost & Staffing p. 16-24
III. Quality Organization Structure p. 25-37
IV. IT Solutions for Quality Activities p. 38-46
V. Managing Document Control p. 47-56
VI. Employing Quality Audits & Management Reviews p. 57-67
VII. Deploying Quality Training p. 68-72
VIII. Managing Software Quality p. 73-79
IX. Managing Supplier Quality & Incoming/Receiving Inspections p. 80-87
X. Managing Manufacturing/Outgoing Inspections p. 88-95
XI. Managing Laboratory Testing & Scientific Quality Processes p. 96-103
XII. Complaint Management & Resolution Activities p. 104-118
XIII. Managing NCE Activity p. 119-124
XIV. Managing Corrections & Removals p. 125-127
XV. Supporting R&D Clinical Trials p. 128-131
XVI. Quality System p. 132-135
XVII. Future Directions for Quality Organization p. 136-143
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11. About Best Practices, LLC
Best Practices, LLC is a research and consulting firm that conducts
work based on the simple yet profound principle that organizations
can chart a course to superior economic performance by studying
the best business practices, operating tactics and winning
strategies of world-class companies.
Best Practices, LLC
6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517
919-403-0251
bestpractices@best-in-class.com
www.best-in-class.com
BEST PRACTICES, ®
LLC