Subtract to Ship: MDR Playbook · Chapter 12 Worksheet
Two-Phase Approach: Phase Assessment & Transition
From Chapter 12: The Two-Phase Approach (Staying Agile in a Rigid World)
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What this worksheet does
Determine whether you are in Phase 1 (research: does this work?) or Phase 2 (medical device development: can we certify this?) and plan the transition. Starting Phase 2 too early wastes years on premature documentation.
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