Founder, Director Regulatory & Compliance
Connie Del Buono, Founder, Director Regulatory and Compliance at Synoptyx Inc.
Connie provides guidance for managing the quality and regulatory functions in medical device companies. She has 36 years experience in the management of in vitro and medical devices manufacturing and their regulation. She has been a Certification Project Manager for a Notified Body for 8 years and continues on contract to perform audits and reviews. She has performed numerous assessments of non-active and in vitro diagnostic medical device dossiers for safety, performance and regulatory requirements for CE marking. Connie is a frequent ASQ and RAPS speaker and teacher in Quality Management Systems and Regulatory compliance and has a focus on the European IVDR. She is Notified Body / Registrar certified in the MDD and IVDD European Medical Device Directives, ISO 9001:2008, ISO 13485:2016 and MDSAP. includes implementing the new IVDR and the 3rd Edition, ISO 13485:2016 as well as the MDSAP. She has also taught IVD compliance at Ohlone College in California and at UC Santa Cruz Extension program.
Saturday, September 21
9:00 AM – 5:00 PM
Tuesday, September 24
2:05 PM – 3:00 PM