AJAX progress indicator
  • Is a matrix tool that assists a cross-functional team in translating customer needs into technical requirements. Read More
  • Collection of processes and procedures to ensure that finished medical devices and/or services will be safe and effective for their intended use. Read More
  • A document which defines the scope of the quality system, an outline of the document structure for quality system documents, documented procedures or reference to them, a description of the interactions between the processes of the quality management system. Read More
  • A document which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. Each manufacturer establishes how the requirements for quality will be met. Read More

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Mary Drotar, Partner

Strategy 2 Market, Inc.



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