Global public health and safety organisation NSF International recently completed the acquisition of Prosystem, a German medical device consulting firm specialising in regulatory affairs and clinical evaluation.
As part of NSF International’s global medical device consulting business, the German company will now be known as Prosystem, an NSF International company.
Europe’s medical device industry is expected to grow at a rate of approximately 10 percent per year while new regulatory requirements create significant opportunities for medical device consulting firms. New EU regulations for medical devices (MDR) and in-vitro diagnostic devices (IVDR) were published in May 2017, establishing new supply chain traceability requirements, new standards for clinical evidence and more rigorous reporting and post-market surveillance requirements.
NSF International says that the acquisition of Prosystem will expand its medical device business in Europe and positions the company to meet an increasing demand for medical device consulting, education and training services in the EU. Additionally, the acquisition provides NSF’s global customers with a deeper knowledge of Europe’s medical device industry and its changing regulatory landscape.
NSF will now also be able to add medical device clinical evaluation, standards engagement and software development to its capabilities.
“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,” said Elaine Messa, president of medical device consulting services at NSF International. “The talented team at Prosystem will help NSF International better serve global clients while also enhancing our services to clients doing business in Europe.”
Founded in 1999 by the late Dr. Jürgen Stettin and Oliver Christ, Prosystem specialises in risk management, quality management, regulatory affairs and clinical evaluations for the medical device industry. The company also provides a variety of other services, including education and training, project management, usability assessments and ISO standards support services.
Prosystem employs 35 people, most located in Germany, and operates offices in Germany, Switzerland, Brazil and the United States. Employees will join NSF International’s 2,730 employees working in 33 countries around the world. The company’s co-founder, Oliver Christ, will join NSF International as executive vice president reporting to Elaine Messa. Randolph Stender will join NSF International and retain his current title of general manager of Prosystem.
Many of NSF International’s medical device experts are former US FDA regulators with knowledge of US and international medical device regulations and standards, including the international Medical Device Single Audit Program (MDSAP). Prosystem clients will also have access to NSF’s many quality management and regulatory training courses.
Beyond medical devices, NSF services include testing, auditing, certification, training and education, and consulting for the global 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,” said Christ. “Both organisations 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.”
