NSF Health Sciences Certification LLC, a wholly owned subsidiary of global public health organization NSF International, has appointed Patricia Serpa as director, lead auditor and expert trainer, Medical Device Regulatory Certification.
 
In this new role, Serpa will serve as a subject matter expert on medical devices and perform quality management systems certifications. With over 10 years of experience in the international medical device and pharmaceutical regulatory field, Serpa will support NSF International’s expanding certification services around the globe.
 
“The medical device industry is becoming increasingly complex and global, which makes Patricia’s regulatory background and industry experience extremely valuable to medical device manufacturers. With NSF Health Sciences Certification recently authorized as an auditing organization for MDSAP, Patricia will play a key role in our organization,” said Brian Ludovico, executive director, MDSAP Regulatory Certification at NSF International.
 
Prior to joining NSF International, Serpa worked as a health regulation specialist with Brazil’s National Health Surveillance Agency (ANVISA). During her tenure she performed international Good Manufacturing Practice (GMP) inspections in the medical device and pharmaceutical industries and served as a GMP trainer for inspectors in both fields.
 
Serpa also served as a liaison to the International Medical Devices Regulators Forum (IMDRF) MDSAP Working Group, where she participated in the creation of the group’s documents and played an important role developing the MDSAP Pilot Program in 2014. To help expand the program, Serpa was appointed MDSAP Assessment Program manager and carried out the assessment of six of the 14 Auditing Organizations currently authorized to perform MDSAP certification.
 
To help develop the MDSAP operational organization, Serpa was also appointed a Quality Management System Management representative under the MDSAP Subject Matter Expert (SME) Working Group, a team responsible for developing, managing and updating the quality management system that governs the MDSAP Regulatory Authority Council and the organization as a whole.
 
In addition, Serpa has significant experience with the Canadian Medical Device Conformity Assessment System (CMDCAS) and she is a liaison to the South American trade bloc Mercosur.
 
NSF International is an independent global organization that writes standards, and tests and certifies products for the health sciences, food, water and consumer goods industries to minimize adverse health effects and protect the environment. Founded in 1944, NSF is committed to protecting human health and safety worldwide. With operations in more than 175 countries, NSF International is a Pan American Health Organization/World Health Organization (WHO) Collaborating Center on food safety, water quality and indoor environment.