| Stark NJ, Biological Safety Quality System, Clinical Device Group Inc, Chicago, IL 1996. References, three-ring bound. $275.00 USD. |
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 single tangible work product.
Table of Contents
Quality Statement
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