Design Controls

Design Control Compliance

Accurately performing and documenting design control is a crucial aspect of meeting 21 CFR Part 820 compliance requirements for medical device companies. ResearchDx can assist in all aspects of the Design control process including:

  • Consulting services ensuring compliance to  CFR Part 820.
  • External compliance and pre-inspection audits
  • Documentation development and review
  • Comprehensive end-to-end implementation
Our Design Control Process Our Design History File Our Quality Process
Medical Device Design Controls

 

Need Assistance,  ResearchDx can help:

  • Design and Development Planning and user needs assessments
  • Design Inputs and Intended Use Requirements
  • Design Outputs to ensure that all design inputs are met
  • Design Review, and the documentation thereof
  • Design Verification of all design inputs and outputs
  • Design Validation of all initial production lots to ensure they meet intended use requirements
  • Design Transfer, ensuring the device successfully moves from development to manufacturing
  • Design Changes to ensure documentation of all validation, verification, review, and approval of design changes.

 

Schedule a consultation to learn more about Design Control Compliance.