Desktop versionhttp://www.markbarbieri.info/Mark H. Barbieri, Quality Engineering, Regulatory Compliance, Quality Management SystemsQuality Engineering and Regulatory Compliance Professional. Experienced in medical device listing and registration, domestic and internationally. Extensive experience in quality management systems, ISO 9001, AS9100, ISO 13485, ISO 14971, EU MDD, FDA 21 CFR 820, Part 11, CMDR SOR-98/282, verification and validation, design controls, Mobile Medical Applications, Medical Device Data Systems, Medical Device Classifications, 510(k) submissions, and more.
Mobile versionhttp://www.markbarbieri.info/Mark H. Barbieri, Quality Engineering, Regulatory Compliance, Quality Management SystemsQuality Engineering and Regulatory Compliance Professional. Experienced in medical device listing and registration, domestic and internationally. Extensive experience in quality management systems, ISO 9001, AS9100, ISO 13485, ISO 14971, EU MDD, FDA 21 CFR 820, Part 11, CMDR SOR-98/282, verification and validation, design controls, Mobile Medical Applications, Medical Device Data Systems, Medical Device Classifications, 510(k) submissions, and more.