Europe’s $101 billion medical device industry is expected to grow at a rate of approximately 10 percent annually while new regulatory requirements create significant opportunities for medical device consulting firms. New European Union (EU) regulations for medical devices and in-vitro diagnostic devices were published in May, establishing new supply chain traceability requirements, new standards for clinical evidence and more rigorous reporting and post-market surveillance requirements.
The acquisition of PROSYSTEM expands NSF International’s 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.
The PROSYSTEM acquisition also expands NSF International’s medical device service offerings by adding medical device clinical evaluation, standards engagement and software development 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 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 specializes 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. PROSYSTEM employees will join NSF International’s approximately 2,730 employees working in 33 countries around the world. The company’s co-founder, Christ, will join NSF International as executive vice president reporting to NSF International’s Messa. Randolph Stender will join NSF International and retain his current title of general manager of PROSYSTEM.
PROSYSTEM clients will benefit from NSF International’s regulatory and technical expertise, global consulting network and expanded range of services. Many of NSF International’s medical device experts are former U.S. Food and Drug Administration regulators with deep knowledge of U.S. 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, where they can learn from former regulators and industry experts.
Beyond medical devices, NSF International services include testing, auditing, certification, training and education, and consulting for the global pharma biotech, dietary supplement, food safety, water quality and environmental sectors. Additionally, NSF International will provide the global resources and systems necessary for PROSYSTEM to grow and meet almost any client need.
“This acquisition makes sense on many different levels for both NSF International and PROSYSTEM,” said Christ. “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.”
Christ is well known in the global medical device community. He is an active member of many international standardization committees such as ISO TC210/JWG1 on ISO 14971, ISO TC215/JWG7 on IEC 80001-1 and IEC TC62/WG on IEC 60601-1 3rd/A2.
NSF International is a global independent organization that writes standards, and tests and certifies products for the health sciences, water, food 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 clients in more than 170 countries, NSF International is a Pan American Health Organization/World Health Organization (WHO) Collaborating Center on Food Safety, Water Quality and Indoor Environment.
NSF International’s medical device services include comprehensive consulting, training and education, and testing solutions to assist medical device companies in navigating international regulatory hurdles throughout the total product lifecycle. Beyond medical devices, NSF’s health sciences services include training and education, consulting, auditing, DNA testing, certification, R&D, regulatory guidance and corporate compliance for the pharma biotech, dietary supplement and bottled water/beverage industries throughout the product lifecycle.