Phil Triolo and Associates

Phil Triolo and Associates is a specialized consulting firm providing regulatory, quality, and clinical affairs services to the medical device and life sciences industries. The firm assists clients in navigating complex FDA and international regulatory pathways, including 510(k) notifications, Pre-Market Approvals (PMA), and Investigational Device Exemptions (IDE). Their expertise covers a broad range of products, including combination products, in vitro diagnostics, and biocompatible materials. In addition to regulatory strategy, the firm provides support for quality system implementation, risk management, and technical documentation. By leveraging deep industry experience, Phil Triolo and Associates helps companies accelerate the transition of innovative healthcare technologies from development to market.