Following what she calls a “wonderful” 25-year career at the FDA, including serving as the agency’s main cheerleader for the International Medical Device Regulators Forum, Kim Trautman has announced that she has taken on a new opportunity at NSF Health Sciences.
Trautman will serve as NSF Health Sciences’ executive vice president, medical device international services, where she says she will be able to pursue her passion of training.
“It was an excellent opportunity at the right time,” Trautman tells IDDM. “The missions of FDA and NSF Health Sciences are very much aligned. NSF Health Sciences is looking to develop a stronger training program, and I am coming on board to expand that.”
Specifically, Trautman will be conducting training courses for industry and manufacturers, as well as those to help build competency for auditors and reviewers. She adds that while there already are strong training programs in the U.S. and EU, she will be working to expand training beyond those realms.
Trautman left her footprint at the FDA with her work on IMDRF, which was established in 2011 to accelerate international medical device regulatory harmonization and convergence.
“IMDRF is ‘firmly established,’” Trautman says. “It has really gotten its feet on the ground.”
She also served as chair of the Medical Device Single Audit Program Regulatory Authority Council, where she will be succeeded by the vice chair from Brazil’s ANVISA.
Since MDSAP's inception, the IMDRF has produced nine documents intended to implement the concept of a single audit program. N3, for example, was produced to explain requirements for auditing organizations and individuals performing regulatory audits.
“They are strong fundamental building blocks for any regulator,” Trautman says.
Trautman acknowledges that the program will face some challenges, but that is true of any new program. She notes that industry will have to get on board with what regulators will be doing going forward — a process that may take some time. Trautman adds that she will be a “very strong supporter” of MDSAP in the future. — Michael Cipriano