Vincent F. Cafiso, Founder, Managing Consultant
About Me
As a former United States Food and Drug Administration (FDA) Investigator with 30-years of industry expertise, I prepare clients to be ready for their next FDA inspection and Notified Body audit in the areas of compliance, quality assurance, and quality systems.
⭐️ 30 years of experience in the creation, maintenance, remediation, and auditing of quality system and technical documentation for sterile and non-sterile medical device and in vitro diagnostics (IVD) companies from startup stage to fully commercial to ensure compliance with domestic and international quality and regulatory requirements.
⭐️ Support clients by providing expertise in building, training, leading, and motivating high-functioning quality and regulatory compliance teams ensuring lasting knowledge transfer and inspection readiness.
⭐️ Talented internal and supplier auditor having practical experience with FDA inspection techniques, Quality System Regulation (QSR and QMSR), and on-site inspection procedures.
⭐️ Proficient in European and Global quality system standards such as ISO 13485, ISO 14971, ISO 9001, and the EU Medical Device Regulations (MD/AIMD, IVD) and associated Technical Documentation.
⭐️ Work extensively with contract design and manufacturing organizations (CDMO) to ensure that product is designed and manufactured in compliance with client, US, and international quality system requirements.
⭐️ FDA-483, Warning Letter, and Consent Decree responses and overall compliance.
Named as one of MD+DI's Top 24 Medtech Voices to Follow in 2024
https://www.mddionline.com/business/24-medtech-voices-to-follow-in-2024