Director of Quality Affairs

Brian Ludovico, Director of Quality Affairs, has over 25 years of experience in quality management systems and global regulatory requirements of medical and in vitro diagnostic devices.  Brian spent 21 years at the European Notified Body TÜV Rheinland.  He took that experience to NSF Health Sciences and, most recently, Thermo Fisher Scientific, where he applied his industry knowledge to implement and streamline quality systems processes and regulatory compliance practices.

As a regulator

  • He audited the quality management system compliance of medical device manufacturers, ranging from start-ups to multi-national organizations, through the review of standard operating procedures, design assurance, risk assessment, and the evaluation of hundreds of product documentation packages (technical files).
  • He set the technical direction for the Notified Body with regard to market access capabilities, accreditation criteria, and competency analyses.
  • He was appointed as the certification manager for the Americas.  In this capacity, he provided the final decision and approval/certification allowing manufacturers to market their products in the European Union and other global markets.
  • For over 10 years, he chaired the certification body group that collaborated with governmental regulators for the development and implementation of global regulatory requirements, such as the Canadian Medical Device Conformity Assessment System (CMDCAS) and the Medical Device Single Audit Program (MDSAP).

As an industry professional

  • Collaborated with jurisdictional representatives during the creation of an MDSAP Auditing Organization and a Notified Body, including the development of a talent competency program and the documentation of over a hundred procedures.
  • Developed quality and regulatory strategies to reduce or eliminate risk as much as possible to meet compliance requirements defined in continually evolving global regulations and standards.
  • Designed, developed, maintained, and improved a range of training and education services, including CAPA and controlled substances academies, and regulatory auditing programs (ISO 13485, MDSAP) to meet market and client needs.
  • Rebuilt and improved the performance of quality and regulatory audit programs by increasing the competency of resources. Brian led a team of contract auditors and regulatory professionals to conduct audits ensuring compliance with governmental and regulatory requirements, international standards, and internal policies.  This included the performance of accurate and unbiased assessments of the organization’s compliance profiles addressing the strength of internal control systems, enhancing cost effectiveness and efficiency of operations, and maintaining proper accountability while managing risk.
  • Designed and developed quality management systems in accordance with recognized standards such as ISO 9001 and ISO 13485, as well as the harmonization of QMSs across large organizational platforms.

Brian received his bachelor’s degree in biology from the University of Connecticut.  Throughout his career, he has been active with the Regulatory Affairs Professional Society and is currently a member the board for the ASQ New England Discussion Group out of Waltham, MA.

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