End-to-End Device Regulation
We help medical device manufacturers navigate the increasingly complex global regulatory landscape, from initial strategy to post-market compliance. Our expertise covers FDA 510(k), EU MDR/IVDR, and global market access.
Gap Analysis & Transition Planning
Comprehensive assessment of your technical documentation against MDR/IVDR requirements.
Learn more510(k) Premarket Notifications
Expert preparation and submission of 510(k) applications to the US FDA.
Learn moreDevice Description & Specification
Detailed technical documentation ensuring alignment with GSPR and essential requirements.
Learn morePre-Submission Meeting Support
Strategic guidance and representation during FDA Q-Submission meetings.
Learn morePMCF Plan Development
Post-Market Clinical Follow-up strategies to strictly monitor device safety and performance.
Learn moreChange Impact Assessment
Evaluating the regulatory impact of design, manufacturing, or labeling changes.
Learn morePMS System Design
Robust Post-Market Surveillance systems compliant with EU MDR and FDA 21 CFR 820.
Learn moreMarket Assessment & Prioritization
Strategic regulatory intelligence to identify efficient market entry pathways.
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