Fabio DePasquale - Senior Consultant, Quality Assurance & Regulatory

Fabio has almost 20 years of experience working for regulated industries in the QA, licensing and medical fields. He has been the main architect for the design and implementation of corporate Quality Management Systems for many Canadian and US medical device firms, and has obtained medical device certifications under the US FDA, Health Canada, and the European Directives for more than 50 medical devices.

Fabio has extensive experience in FDA GMP and ISO 13485:2003 compliance, SOP development and ISO 14971 risk management and analysis. In addition, he has been actively involved the preparation of applications for US (IDE), Canadian (ITA) and Europe, and is knowledgeable in the areas of EMC compatibility, biocompatibility, laser, ultrasound and lab system requirements.

EXPERIENCE:

Director of QA and Regulatory Affairs, StarFish Medical (2003-2006)

• Designed a corporate Quality Management System (QMS) in compliance with ISO 13485, US federal quality system regulations (QSR) and CMDCAS (Canadian) requirements.
• Developed manufacturing testing and verification controls according to six-sigma methodology.
• Provided training, auditing support and enforcement on all activities covered by the QMS.
  
• Prepared regulatory submissions to US (510k), Canadian (MDL), and European (Technical Files)regulatory authorities for over ten different medical devices.
• Designed in-vivo clinical studies in compliance with the ISO 14155 and international requirements.
• Participated in product development activities including preparation of quality plans and risk analyses in compliance with the ISO 14971 requirements.
• Established labelling criteria in compliance with international regulatory requirements.
• Managed third party testing against medical electrical systems (601-1), EMC compatibility (601-1-2), laser (601-2-22), ultrasound (601-2-37), laboratory systems (61010) and biocompatibility (ISO 10993) requirements.
• Developed regulatory strategies for new products, changes to existing products, or new indications for use.
• Conducted post-marketing surveillance, medical vigilance reporting, product recalls, and event investigations in compliance with current domestic and international requirements.
• Liaised with regulatory authorities including FDA, Health Canada, Notified Bodies and other agencies.

Quality Assurance Consultant, De Pasquale Consulting (2003)

• Provided consulting services to local companies in the areas of quality assurance, design control, change control, documentation and records control, purchasing, nonconforming products, internal audit, corrective and preventive actions, customer service, calibration, vendor qualification, incoming inspections, etc.
• Developed and implemented ISO 9001 compliant quality systems for companies of a wide range of industries, such as waste water processing, system automation and software development.
• Conducted on-site training and seminars for local companies in the area of quality assurance.

Product & Project Manger, Hydroxyl Systems Inc. (2002-2003)

• Managed the construction of multi million dollar marine wastewater treatment systems on large cruise ships, from design to final commissioning and testing.
• Interfaced with major client corporations during the definition of system specifications and project proposals.
• Streamlined and managed the operation of the Purchasing and Inventory Control department.

Licensing Officer, Canadian Nuclear Safety Commission (1993-2001)

• Presented licensing advice and regulatory recommendation before the Board.
• Conducted licensees inspections and audits to verify compliance with quality and safety requirements.
• Managed public consultation hearings in accordance with federal regulations.
• Developed a Licensee Performance Measurement System for the evaluation of licensing submissions.
• Developed policies and guidelines in the area of power plant licensing.
• Liaised with other federal agencies with respect to the implementation of federal regulations.

Nuclear Safety Specialist, National Nuclear Research Centre of Switzerland (1989-1993)

• Performed safety analyses and inspections of nuclear power plants.
• Conducted verification and validation of computer codes.
• Presented numerous technical papers and lectures at international conferences and workshops.
  

Post Graduate Student, Centre for Nuclear Studies in France (1987-1988)

• Developed physical models used in safety analysis computer codes.

AREAS OF EXPERTISE:

Devices:

• Medical lasers.
• Ultrasound equipment.
• All devices with an electronic component or software.
  

QA & RA:

• Canadian Medical Device Regulations (CMDR)
• FDA Quality System Regulations (21 CFR Part 820)
• European Medical Device and IVD Directives
  
• EMC compatibility, biocompatibility, laser, ultrasound and lab system requirements.
• Software validation.

CERTIFICATIONS:

• US Regulatory Affairs Certification (RAC) - Regulatory Affairs Professional Society (pending)
  
• ISO 13485:2003 Internal Quality Auditor Training - BSI Product Services

EDUCATION:

• MBA in Engineering Management, University of Ottawa, Canada
• M.Sc. in Mechanical Engineering, University of Pisa, Italy

HOME BASE:

• British Columbia, CANADA