Stage 03 · Medical Device Track

Verification, Validation & Submission

Engage FDA strategically, plan your testing, then assemble the submission.

The temptation in Stage 03 is to skip directly to the 510(k) and figure out the testing later. That order has bankrupted companies. The chronologically correct sequence starts with the Pre-Submission (Q-Sub) Strategist — a free FDA meeting that, done well, saves 6–12 months of wrong-path development. Only after FDA has signaled how they think about your device do you commit to the Test Plan that specifies what to actually run. The 510(k) Submission Builder comes last, assembling completed test results into RTA-checklist-compliant sections.

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.

Step 1

Active

Pre-Submission (Q-Sub) Strategist

A Q-Sub is a free FDA meeting where you ask specific strategy questions before committing to expensive testing or submission. Done well, it saves 6-12 months of wrong-path development. Done badly, it wastes the chance. This card structures the question crafting, evidence package, and meeting prep.

Launch Tool

Step 2

Active

Test Plan & Protocol Generator

Given device class and predicate: biocompatibility (ISO 10993 matrix), electrical safety (60601), EMC, mechanical performance, sterility (ISO 11135/11137), shelf life (ASTM F1980), software (IEC 62304), animal, clinical. Sample-size justified, budget-estimated.

Launch Tool

Step 3

Active

510(k) Submission Builder

Substantial equivalence comparison table, Indications for Use, device description, performance testing matrix, labeling, biocompatibility, sterilization, software, electrical safety, EMC, traceability matrix, FDA eCopy format. RTA-checklist verified.

Launch Tool