Biological Safety Quality System Manual

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