· 2 min read
HAMBURG, Germany – PROSYSTEM, an NSF company, is expanding NSF’s services to the European Union’s medical device and pharmaceutical manufacturing industries with the opening of a new regulatory training facility in Hamburg, Germany.
“In the last 12 months, NSF has invested strategically in European regulatory training, by adding eight new positions to our Hamburg team, which will help our clients in many ways,” said Oliver Christ, Executive Vice President of PROSYSTEM. “NSF’s new training center in Germany expands our regulatory training and education programs to better support medical device and pharmaceutical manufacturers competing in the fast-changing European marketplace.”
The expansion doubles the existing office space with an additional floor in the Berliner Tor Center, one of Hamburg’s tallest office buildings.
NSF opened the new training center in anticipation of a rise in the need for regulatory education, especially as the deadline for the European Union Medical Device Regulation (EU MDR) 2017/745 enters into force on May 26, 2020 and the In Vitro Diagnostic Medical Devices Regulation (EU IVDR) 2017/746 enters into force in May 2022. On that date, EU MDR 2017/745 and EU IVDR 2017/746 will effectively dictate market access for all members of the European single market. To prepare for that looming enforcement deadline, the new NSF training center will offer programs designed to train manufacturers in understanding compliance with EU MDR 2017/745 and EU IVDR 2017/746, and to maintain consequent CE mark certification and access to the European single market.
Classes at NSF’s Hamburg training center begin in December with an official grand opening event on December 5, 2018.
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NSF is an independent, global organization that facilitates standards development, and tests and certifies products for the health sciences, food, water 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 operations in more than 175 countries, NSF is a Pan American Health Organization/World Health Organization (WHO) Collaborating Center on Food Safety, Water Quality and Indoor Environment.
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, medical device, dietary supplement and bottled water/beverage industries throughout the product lifecycle. NSF facilitated the development of the only American National Standard (NSF/ANSI 173) that verifies the health and safety of dietary supplements and also tests and certifies products to this standard.
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