Phase 0

 

  Phase 1

 

Phase 2

 

Phase 3

  • Verify risk controls

  • Following verification protocols, test product and report results

  • Produce a trace matrix

  • Update design history file (DHF) and output device master record (DMR) and device history record

  • Produce a technical file

  • Provide Regulatory input, compliant with 510(k) 

  • Conduct formative studies

  • Produce documents & report results

 

Phase 4

 

Phase 5

  • Transfer design files to manufacturer

  • Feed RM results into manufacturing

  • Conduct process Failure Mode Effects Analysis (pFMEA)

  • Initiate supply chain

  • Update device master record (DMR)

  • Report results

 

Overview: Informed Design Process
Aproio: we analyze, design, build & test medtech and other highly regulated products