Platform / Medical Device / Stage 06 · Post-Market
Stage 06 · Medical Device Track

Post-Market

Vigilance from day one of clearance, expansion when the US base is stable.

Stage 06 begins the day the FDA letter arrives. Post-Market Surveillance is a regulatory obligation from day one — complaint handling, MDR/Vigilance reporting decision trees, periodic safety updates. International Expansion is a forward-looking strategic activity that begins only when the US base is producing reliable real-world evidence and the manufacturing is stable enough to support new geographies. Sequencing both correctly is the difference between a clean inspection record and a recall.

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 05 · Commercial & Reimbursement Stage 07 · Business & Capital
Step 1
Active
Post-Market Surveillance
Complaint handling system, MDR decision tree (21 CFR 803), CAPA workflow, trend analysis structure, and the PSUR template. Required from day one of clearance. Operationalizes the surveillance loop and prepares every SOP and template that must exist before first sale.
Launch Tool
Step 2
Coming Soon
International Expansion
EU MDR / IVDR, Health Canada, TGA (Australia), PMDA (Japan), ANVISA (Brazil), NMPA (China). Pathway summaries, gap analysis from FDA clearance to each market, in-country authorized representative requirements. Unlocks once platform adoption produces sufficient cross-jurisdiction usage data.
Coming Soon