Sean joined Experien Group (now Veranex) in 2009 and possesses more than 20 years of experience in the medical device industry. He has particular expertise in the development and implementation of quality management systems that comply with the FDA’s Quality System Regulation 21 CFR Part 820, ISO 13485, EN ISO 14971, IEC 60601 electrical equipment series of standards, the European Medical Device Directive (MDD), and other relevant standards. Sean is an expert in software validation for medical devices and Software Life Cycle Management (EN IEC 62304). He has designed and implemented clean rooms for medical device manufacturers (up to Class 10) and he has been personally responsible for large- scale projects in quality assurance and manufacturing process validation, including extensive experience with technology transfers.

At Veranex, Sean manages the quality team. He holds particular expertise in software-based technologies as well as usability engineering standards (EN 62366) for complex medical devices. Sean supports clients’ regulatory submissions (U.S. and international) and he functions as companies’ interface with regulatory agencies through audits and inspections. His central responsibilities include:

  • Quality management system development and compliance to relevant standards
  • Manufacturing and distribution considerations (e.g., supplier quality, design control, and risk management)
  • Interface with FDA inspectors, notified body auditors, and state of California Food and Drug Branch (FDB) inspectors
  • Software Life Cycle Management for stand-alone medical software products as well as devices incorporating software (e.g., wearable technologies, mobile medical apps, sensor-based diagnostics, capital equipment)
  • Internal audits, supplier audits, and management reviews for companies
  • Quality requirements and regulatory submissions for CE marking

Past companies and experience
Sean’s professional career began in 1982 at Dysan Corporation (sold to Xidex Magnetics) in process engineering for the manufacture of computer information storage products. In 1995, he transitioned to the medical device sector, holding management positions at several medical device companies, including Acuson, Siemens Medical Solutions, and Boston Scientific. He has completed AAMI Certification for Mastery of the Quality System Regulation and a Lead Assessor Program for ISO 9000 with emphasis on ISO 13485. He was a certified instructor on process validation for Siemens Medical Solutions and Boston Scientific and a course instructor for De Anza College Center for Applied Competitive Technology. He has also performed as a Sarbanes Oxley (CSA) auditor, ISO 9000 certification coordinator, and ISO 13485 auditor.

Education
Sean received a B.S. in chemical engineering from San Jose State University in San Jose, California.

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