Platform / Medical Device / Stage 02 · Design & Development
Stage 02 · Medical Device Track

Design & Development

Establish the design controls framework, then populate it with engineering work.

Design controls aren't paperwork bolted on at the end — they are the structure that holds engineering decisions. Stage 02 sets up the framework first (DHF Index, Risk Management File, Human Factors) so that every engineering analysis produced afterward has a place to live and a traceable purpose. The Reverse Engineering, Device Analyzer, and Assembly Analyzer tools then generate the technical content that fills those frameworks: BOMs, PFMEAs, dimensional studies, materials identification — each one logged as a DHF entry, each one linked to a risk control or design input.

Cards below are arranged in chronological use order. Step numbers reflect the recommended sequence; an experienced practitioner may interleave or revisit cards as needed, but a first pass through this stage should follow the order shown.
Stage 01 · Concept & Strategy Stage 03 · Verification, Validation & Submission
Step 1
Active
Design Controls / DHF Index
21 CFR 820.30 traceability matrix: User Needs → Design Inputs → Design Outputs → Verification → Validation. Design Review milestones, Design Transfer checklist. Living DHF documents. The framework every engineering analysis files into.
Launch Tool
Step 2
Active
Risk Management File (ISO 14971)
Full risk management file: hazard identification, risk analysis, evaluation, control, residual risk acceptability, post-production monitoring plan. Distinct from PFMEA — this is the FDA-submission document. Established early; lives throughout the project.
Launch Tool
Step 3
Active
Human Factors / Usability (IEC 62366)
Use environment analysis, user profiles, use-related risk analysis, formative study protocols, summative validation study, HFE/UE summary report. The deliverable FDA asks for in the deficiency letter you don't want.
Launch Tool
Step 4
Active
Reverse Engineering
Tear-down a competitive or legacy device. BOM reconstruction, process inference, dimensional capture from samples, materials ID, supplier identification. Outputs feed your DHF and predicate comparison.
Launch Tool
Step 5
Active
Device Analyzer
USPTO patents, FDA classification, PFMEA / Risk, process and metrology flow, validation plan, batch record, RFQ, cost & ROI. Single device or bulk Excel upload. The single-component engineering deep-dive.
Launch Tool
Step 6
Active
Assembly Analyzer
Upload an assembly BOM. Auto-classify custom vs off-the-shelf, attach drawings per custom row, run the full analysis on each custom component, export one combined assembly report.
Launch Tool