Fractional and project-based regulatory affairs support for Class I/II medical device companies — from first regulatory hire to full compliance program buildout.
FDA Submissions & Predicate Strategy
510(k) submission strategy and predicate analysis, FDA establishment registration, and device listing — built for Class I/II devices moving toward clearance.
QMS Development
Quality management system buildout aligned to ISO 13485 and 21 CFR 820, including CAPA and complaint handling systems, supplier qualification and quality agreements, and internal/external audit preparation.
UDI/GUDID & Labeling
UDI/GUDID program development through GS1, plus label gap analysis and compliance remediation to close coverage gaps before they become enforcement risk.
Risk Management & Sterilization
Risk management programs under ISO 14971:2019, and sterilization validation support aligned to AAMI ST98 and ISO 17664.
eQMS Evaluation & Global Strategy
eQMS platform evaluation and implementation support (Greenlight Guru, ZenQMS, Dot Compliance, SmartSuite, EVO820), plus global regulatory strategy for companies entering new international markets.