Howell brings more than 25 years of U.S. FDA experience to NSF International

ANN ARBOR, Mich. – NSF International, a leading provider of regulatory compliance, quality systems, analytical testing, education and consulting services for the medical device sector, has appointed Heather Howell Executive Vice President of Training and Internal Quality Management Systems for the NSF Health Sciences Medical Devices group based in Washington, D.C.

Howell, an expert in developing educational programs for the medical device industry, brings more than 25 years of U.S. Food and Drug Administration (FDA) experience to NSF International. At FDA, she led the development of blended learning programs and worked with the medical device industry and trade associations to identify and fill crucial knowledge gaps. In her new role, she’ll help to expand NSF’s current U.S. and European medical device training internationally, grow certification training programs and ensure that NSF offers customized and innovative training solutions to meet client needs and help them comply with the ever-changing medical device regulatory landscape.

At the U.S. FDA, Howell served as the Deputy Director, Office of Communication and Education in the Center for Devices and Radiological Health (CDRH), developing benefit-risk information and implementing communication strategies for high-risk safety issues. Her expertise offers NSF International’s clients solutions to minimize patient risk through effective communication, ensuring public trust and credibility for their company. These services will ensure that client communication strategies are consistent with FDA directives and communication policies, such as the recently issued Emerging Signals Draft Guidance Document, which proposes that the Agency notify the public of emerging safety signals earlier than the traditional FDA Safety Communication process.

“An effective communication strategy is critical to mitigate patient risk and meet regulatory directives,” said Kim Trautman, Executive Vice President of International Regulatory Compliance Services for NSF International’s Medical Devices group. “Howell’s extensive experience in developing and implementing risk communication strategies for U.S. FDA will bring valuable expertise to NSF International clients.”

Howell has a bachelor’s degree in behavioral science from the University of Maryland and master’s certificates in both program management and organizational leadership from George Washington University’s School of Business in Washington, D.C.

For more information about NSF International medical device services, please contact Chau Agon at hs@nsf.org or call +1 202-822-1844.

Editor’s note: To schedule an interview with an NSF International medical device expert, please contact Liz Nowland-Margolis at media@nsf.org or +1 734-418-6624.

About NSF International: NSF International is an independent global organization that writes standards, and tests and certifies products for the building materials, food, water, health sciences and consumer goods industries to minimize adverse health effects and protect the environment (nsf.org). Operating in more than 165 countries, NSF International is accredited by the American National Standards Institute (ANSI) and is a Pan American Health Organization/World Health Organization Collaborating Center on Food Safety, Water Quality and Indoor Environment.

The NSF Health Sciences Division which includes NSF Medical Devices, offers training and education, consulting, auditing, GMP and GLP testing, DNA testing, certification, R&D and regulatory guidance for the pharmaceutical, medical device, dietary supplement and bottled water/beverage industries throughout the product life cycle.