NSF International recently acquired German medical device consulting firm Prosystem AG, expanding its medical device consulting services into Europe.
The company’s acquisition helps expand medical device business into Europe and allows NSF International to meet an increasing demand for medical device consulting, education and training services in Europe. It also allows NSF International’s customers to have a better understanding of the medical device industry and its changing regulatory landscape in Europe.
Prosystem also adds medical device clinical evaluation, standards engagement and software development capabilities to NSF International’s offerings.
“The European medical device market is the second largest in the world, so it is very important for our global clients selling products in the EU,” Elaine Messa, NSF International’s president of medical device consulting services, said. “The talented team at ProSystem will help NSF International better serve global clients while also enhancing our services to clients doing business in Europe.”
Prosystem specializes in risk management, quality management, regulatory affairs and clinical evaluations while providing other services like education and training, project management, usability assessments and ISO standards support services. The company currently employs 35 people and has offices in Germany, Switzerland, Brazil and the U.S.
Clients from Prosystem will be able to take advantage of NSF International’s regulatory and technical expertise, global consulting network and expanded range of services. A lot of NSF International’s medical device experts are former FDA regulators who have a better understanding of U.S. and international medical device regulations and standards.
NSF International also offers testing, auditing, certification, training and education and consulting for pharma biotech, dietary supplement, food safety, water quality and environmental sectors.
“This acquisition makes sense on many different levels for both NSF International and Prosystem,” Oliver Christ, executive VP of Prosystem, said. “Both organizations approach the medical device industry from a scientific, public health perspective and both adhere to the highest quality standards. As an NSF International company, we will be able to grow our operations, enhance technologies and serve Prosystem’s clients in exciting new ways, helping them navigate the changing regulatory environment in Europe.”
(See the best minds in medtech live at DeviceTalks West, Dec. 11–12 in Orange County, Calif.)