ENZO PASSALIA QUALITY SYSTEMS AND REGULATORY SPECIALIST

Mr. Passalia has over 20 years’ experience in medical device quality management for companies manufacturing items from single-use devices to complex, high-risk electromechanical devices. Mr. Passalia has served as quality manager in two device companies, and managed the introduction of quality management systems (QMS) in both. He is expert in both US Food and Drug Administration (FDA) and European QMS compliance, including such critical areas as process validation, complaint handling, and incident reporting. 

Mr. Passalia trained as an industrial chemist in Milan before joining the medical device industry, and he also has experience of merging the requirements of ISO 14001 into an existing QMS.

In his most recent role before joining Donawa Consulting, Mr. Passalia was Divisional Customer Support Manager for a multinational device company, responsible for providing technical support to the organization’s service departments, including field service. He was also responsible for complaint handling and incident notification to the relevant regulatory agencies.

Mr Passalia can help you with: 

  • Quality management system implementation to meet ISO 9001, ISO 13485, and US FDA 21 CFR 820/803/806
  • Gap analysis of existing quality management systems to meet additional requirements
  • Development of standard operating procedures forming part of a quality management system
  • Vigilance reporting to US and European regulatory agencies
  • Process validation of manufacturing and control processes, including sterilization