Pre-money valuation is the agreed equity value of a company before a new financing closes. Post-money valuation equals pre-money plus the new investment. The price per share in the round equals pre-money divided by fully-diluted shares outstanding (including option pool top-ups). Investors often require the option pool to be expanded before the round, which lowers the effective pre-money valuation for existing holders. Converting SAFEs and notes also affect the share count used to set the price. Comparing offers on price per share and fully diluted ownership is more accurate than comparing headline valuations.

Why it matters

Pre-money pricing is the central negotiation in any priced round. In MedTech, comparable companies, comparable transactions (M&A multiples on revenue or enterprise value per installed base), and risk-adjusted NPV of the lead program drive the discussion.

Common pitfalls

•Forgetting that an option pool 'top-up' typically comes out of pre-money, diluting founders not investors.

Sources

PitchBook - MedTech Coverage · PitchBook
NVCA Model Documents · NVCA
Silicon Valley Bank - Healthcare Reports · SVB
SEC capital-raising glossary: valuation · U.S. Securities and Exchange Commission

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Why compare MedTech terms side by side?

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.

Each comparison on this page pulls from the same vendor-neutral, sourced definitions used throughout the MedTech Terms glossary. You see the one-line summary, the formal definition, why it matters in practice, common pitfalls, and the primary sources (FDA guidance, EU MDR/IVDR articles, ISO/IEC standards, MDCG documents, IMDRF principles) that back each entry. That makes the comparison defensible in regulatory strategy memos, design reviews, and submission narratives.

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.

How to use this tool

Pick term A and term B from the dropdowns, or click a preset above. The URL updates with both slugs so you can bookmark or share the exact comparison with a colleague, a notified body reviewer, or your regulatory consultant. Click Open full page on either side for the complete entry, including FAQs, related terms, and the full citation list. If you are not sure which term to start with, browse the Categories view or the A-Z index.

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.