Our Services

Flexible consulting tailored to your stage, scope, and success.

Regulatory Strategy

Feedback and analysis on pathway evaluation, product labeling, labeling claims, 510(k) preparation, MDR compliance, and global regulatory guidance.

Design Verification & Validation

Protocol development, execution, and documentation for Class II and III medical devices.

Product Development Processes

From feasibility to design transfer and post-market, we support every stage of innovation in implantables.

Risk Analysis

EN ISO 14971:2019 compliance analysis and recommendations. PHA, dFMEA, pFMEA, uFMEA and beyond.

Quality System Reviews

Change control, compliant handling, CAPA. Achieve compliance without undue burden.

Technical Advisory

Expert reviews, gap analyses, and fractional leadership for medtech startups. SMEs available on a variety of topics. Product portfolio assessment, analysis, and insights.