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Quality Systems Quality System Regulations (QSR's) and Good Manufacturing Practices (GMP's) are necessary to ensure that manufacturers of medical devices and drugs have a formal quality system in place for designing and producing products for market in the United States. The FDA inspects manufacturing operations and their records to determine compliance with QSRs. QSRs are quite encompassing. They cover management and organization, device design, buildings and equipment, purchase and handling of components, production and process controls, packaging and labeling control, device evaluation, distribution, installation, complaint handling, servicing, and record keeping methods. Regulatory Specialists, Inc. is a seasoned expert in helping companies develop their Quality Systems throughout the World. We also provide valuable assistance by auditing clients before inspections and by directly assisting companies during FDA and ISO inspections.
Quality System Services
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