...quality strategies, quality systems, audits, quality assurance
...validation master plans, programs and reports
...requirements of regulatory authorities, standards for clean rooms, quality standards, technical standards

Quality

Creating a well-defined and measurable quality strategy is important right at the start of a company’s operational lifetime. A functioning quality system helps to establish customer confidence in the quality of the work being done within the company.

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Validation

Well-defined and structured validation programs ensure that the company’s products, premises, devices, information systems and production processes are secure and reliable in their function.

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Regulatory authorities

The requirements of the various regulatory authorities must be considered and fulfilled in areas such as the marketing of medical devices, building quality systems, and the special requirements for clean rooms/clean areas.

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