Written for a model start-up company, our quality system is a composite of common features from a variety of medical device manufacturers. It is compliant: assuring that your procedures will meet regulations and international standards. It is comprehensive: all important aspects of biological safety are addressed. It is editable: provided on paper copy and on diskette, it is designed for you to customize. Each standard operating procedure describes a single work activity and results in a tangible work product. For more details consult our catalog.
Contents
Stark NJ, Biological Safety Quality System, Clinical
Device Group Inc, Chicago, IL (2006).
References, three-ring bound. $275.00 US.
Quality Manual
Operations Manual
Standard Operating Procedures: Request for Biological Safety Evaluation…Developing a Test Plan for Prototype Review…Developing a Test Plan for Prepilot Review…Submitting a Material Quantity Request…Ordering a Biological Safety Test…Issuing Biological Safety Reports…Managing Positive Test Results…Maintaining a Biological Safety Evaluation File…Issuing a Device Safety Release…Reviewing Device Labeling…Device Safety Monitoring Program…Conducting a Contract Laboratory Quality Audit