Design Control Planning and Review

All successful regulatory submissions are supported by FDA compliant Design Control and Review systems. Design Control is much more than writing a change order. Compliant medical device development requires:
  • Quality System documented SOPs
  • Design Level Hazard Analysis and Risk Assessment
  • Documented customer inputs
  • Verification and/or validation tied to risk analysis and technological difference
  • Soundly crafted output documentation
  • Thorough design transfer and process validation
  • A documented development plan that supports the product development process
Quality System Regulations (QSRs), and ISO 13485:2016 require documented design review according to written procedures, with results maintained in a documentation system (Design History File). Paladin Medical will guide you in documenting and maintaining:
  • Design plans
  • Design review meetings
  • Change control for documentation of changes to design inputs and outputs