Medical Device Global Compliance Cost Calculator

2025 Edition | Estimate regulatory costs across key global markets

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Medical device compliance cost calculator for 2025 launches

Use this medical device regulatory cost calculator to model MDR, FDA 510(k), PMA, UKCA, and global approvals with realistic 2025 pricing for notified body fees, quality management setup, translation, travel, and clinical studies. It helps startups, scaleups, and enterprise teams compare markets, set budgets, and align board expectations before green-lighting design freeze or pivotal trials.

Plan smarter budgets

Quickly see how EU MDR vs. FDA 510(k)/De Novo vs. PMDA approvals shift cost and timelines, including consultant support and QMS implementation.

Compare markets

Toggle CE Mark, UKCA, NMPA, TGA, and ANVISA to see where shared evidence, translations, or local testing change your spend.

De-risk timelines

Estimate 4–36 month windows based on risk class and experience so hardware, SaMD, and IVD teams can sequence submissions.

When to use this calculator

  • Pre-Board budgeting for MDR Class IIa/IIb/III or FDA 510(k)/De Novo/PMA pathways
  • Building a business case that includes notified body, ISO 13485, and IEC 62304 costs
  • Choosing launch sequence across EU, USA, UK, Japan, China, and emerging markets
  • Estimating the lift for SaMD Rule 11 classifications vs. low-risk accessories
  • Setting realistic contingency for translations, audits, and travel

These numbers use industry midpoint benchmarks and assume standard MDR/FDA expectations. Always validate with your notified body or regulatory consultant for device-specific nuances.