Regulatory

ZoZo Engineering has extensive experience making sure products meet regulatory requirements. With any product development, regulatory requirements should be identified and addressed in the initial requirements phase. Products designed without a focus on final regulatory approval end up being delayed for release and worst yet having to be sent back to the design phase. ZoZo Engineering provides the following regulatory services to make sure your product launches on time and approved.

FDA TUV CE
  • Identify applicable regulatory directives and harmonized standards (CE, EN, IEC, UL)
  • Identify Conformity Assessment Modules
  • Review regulatory standards and document necessary product requirements to meet standards
  • Develop regulatory approval plan including identifying product criticality
  • Develop V&V plans for safety critical products
  • Document Hazard Analysis and FMEA/Fault Tree Analysis
  • Perform and document Verification testing with full coverage assured by Traceability Matrix
  • Establish and maintain Design History File
  • Perform formal documented Design Reviews
  • Maintain ECO process and documentation
  • Document safety agency Technical File
  • Design and produce IFU and product labeling
  • Support EMC lab testing
  • Support Safety and Regulatory lab submissions and testing
  • Obtain CB Scheme, TUV, Nemko, CE, UL safety markings
  • Support FDA approval submissions
  • Provide comprehensive and complete transfer-to-manufacturing packages
  • Support client ISO 9001, ISO 13485, and GMP Quality Management Systems

Archives

Categories

  • No categories

Featured