Flexible consulting tailored to your stage, scope, and success.
Feedback and analysis on pathway evaluation, product labeling, labeling claims, 510(k) preparation, MDR compliance, and global regulatory guidance.
Protocol development, execution, and documentation for Class II and III medical devices.
From feasibility to design transfer and post-market, we support every stage of innovation in implantables.
EN ISO 14971:2019 compliance analysis and recommendations. PHA, dFMEA, pFMEA, uFMEA and beyond.
Change control, compliant handling, CAPA. Achieve compliance without undue burden.
Expert reviews, gap analyses, and fractional leadership for medtech startups. SMEs available on a variety of topics. Product portfolio assessment, analysis, and insights.