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Design Control

Reduce costs and time to market with efficient development systems!

All successful regulatory submissions are supported by FDA compliant Design Control and Review systems. Quality System Regulations (21 CFR 820: QSRs) and ISO 13485 require documented design review according to written procedures, with results maintained in a documentation system (Design History File). FDA has announced the transition to “QMSR,” explained more fully in STAYING CURRENT. According to the 89 FR 7496 the regulation “incorporates” Design and Development, Clause 7.3, and its Sub-clauses in ISO 13485.

For companies familiar with Design Control and Review, the transition should be primarily a job of re-indexing the similar requirements you have in your QSR documents. For a start-up medical device project, you may need help implementing.

Paladin Medical is ready to guide you through the steps and documentation obligation:

  • Quality System documented SOPs
  • Design plans
  • Design review meetings
  • Change control for documentation of changes to design inputs and outputs
  • Design History File and development records
  • Documented customer inputs
  • A documented development plan that supports the product development process
  • Design Level Hazard Analysis and Risk Assessment
  • Design verification and/or validation tied to risk analysis and technological differences Read more about Qualification
  • Soundly crafted output documentation relevant to regulatory submissions and compliant with standards and guidance document requirements
  • Design transfer and process validation Read more in Qualification