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Quality Systems

Quality System Regulations (QSRs) and Good Manufacturing Practices (GMPs) 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.

Quality System Certification
Many companies that embark on ISO 9000 or 13485/8 registration and CE marking authorization for their products take advantage of our money and time saving combined audit process. QSOne works with you to develop a combined audit plan for the registration to appropriate ISO standards and to the Medical Device Directive. The result is one audit process that meets both your European regulatory and worldwide marketing needs. QSOne 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.