Facility provides an educational programme designed to help medical device manufacturers comply with EU regulations
Prosystem, an NSF International company, is opening of a training facility in Hamburg, Germany. Located in the Berliner Tor Center, the new location expands its services to the European Union’s medical device and pharmaceutical manufacturing industries.
“In the last 12 months, NSF International 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 VP, of Prosystem.
He continued: “NSF’s new training centre in Germany expands our regulatory training and education programmes 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 and the In Vitro Diagnostic Medical Devices Regulation (EU IVDR) 2017/746, both adopted in 2017, enters into force on May 26, 2020.
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 centre 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 centre begin in December with an official grand opening event on December 5, 2018.