NSF International has acquired 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 well-respected German company will be known as ‘PROSYSTEM, an NSF International company’.
Europe’s $101bn medical device industry is expected to grow at a rate of approximately 10% a 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.
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.
In addition, 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.
President of medical device consulting services at NSF International Elaine Messa said: “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.
“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, mostly located in Germany, and operates offices in Germany, Switzerland, Brazil, and the US. PROSYSTEM employees will join NSF International’s approximately 2,730 employees working in 33 countries worldwide. The company’s co-founder, Oliver Christ, will join NSF International as executive vice-president reporting to NSF International’s Elaine 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 vast regulatory and technical expertise, global consulting network, and expanded range of services. Many of NSF International’s medical device experts are former US Food and Drug Administration (FDA) regulators with deep 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, where they can learn from former regulators and industry experts.
Beyond medical devices, NSF International services include testing, auditing, certification, training, and education, as well as consulting for the global pharmaceutical biotech, dietary supplement, food safety, water quality, and environmental sectors. In addition, NSF International will provide the global resources and systems necessary for PROSYSTEM to grow and meet almost any client need.
Executive vice-president of PROSYSTEM, an NSF International company Oliver Christ said: “This acquisition makes sense on many different levels for both NSF International and PROSYSTEM.”
“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.”
Oliver Christ is well known in the global medical device community. He is an active member of many international standardisation 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.