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Quality & Regulatory
TDC has on-site personnel with experience and expertise in a broad range of quality system activities and regulatory affairs services. We are certified to ISO 13485:2003 through BSI, and also have a full quality system that complies with the FDA's 21 CFR Part 820. At TDC we can support your company from product design and development through clinical studies. Our expertise is in the following areas:• Customizing a quality system to meet your specific company needs and business objectives • Auditing of suppliers to ISO 13485:2003 and QSR • Development of procedures and processes to support your project • Regulatory submission support, including drafting of submissions • Oversight and ongoing support of your contract sterilization vendors • Programs for biocompatibility and sterility testing • Clean room and environmental monitoring • Document control through the Document Change Order process • Completed documentation packages: — Design History Files — Device Master Records Services Concept/Brainstorming • Design • Development • Manufacturing • Quality & Regulatory |
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