Launch readiness is the structured cross-functional gate that confirms a device is ready for commercial release - regulatory clearance, QMS state, supply capacity, sales training, KOL engagement, reimbursement strategy, and post-market surveillance plan. Readiness covers regulatory clearance, supply and manufacturing scale-up, coding and payment, sales training, complaint handling and post-market surveillance. Teams usually use a cross-functional checklist with go or no-go gates. Gaps in reimbursement or supply are common causes of slow launches.

Why it matters

Missing any one element can stall launch. CMO, CCO, and Quality VP typically co-own the gate.

Common pitfalls

•Assuming regulatory clearance or approval alone signifies launch readiness without considering other critical elements.
•Failing to integrate regulatory and quality milestones into the overall launch readiness checklist.
•Underestimating the resources and time required for effective sales force training and post-market surveillance infrastructure.
•Neglecting to update launch readiness criteria based on evolving regulatory requirements or market conditions.

Sources

AdvaMed product launch · AdvaMed
AdvaMed Code of Ethics · AdvaMed
AHRMM - Healthcare Supply Chain · AHRMM
FDA device regulation: prerequisites for commercial distribution · U.S. Food and Drug Administration

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MedTech terminology is full of pairs that look interchangeable but carry very different regulatory, clinical, and commercial consequences. Picking the wrong framework, pathway, or standard early in a project can add months to a submission, invalidate clinical evidence, or trigger an audit finding. Side-by-side comparison is the fastest way to surface those differences before they become costly mistakes.

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Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

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MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.