Biotechnology company Nordberg Medical has achieved certification under the European Union’s Medical Device Regulation (MDR) and the Medical Device Single Audit Program (MDSAP).
The MDR certification confirms that skin booster JULÄINE complies with the EU’s regulatory requirements for medical devices. MDSAP certification, meanwhile, confirms that Nordberg Medical’s quality management system meets regulatory requirements across participating markets, including the US, Canada, Australia, Brazil and Japan.
The EU’s MDR framework places greater emphasis on clinical evidence, risk management and product traceability. It also requires manufacturers to continuously monitor the safety and performance of medical devices after they enter the market.
Sílvia Alexandra Fernandes, chief regulatory affairs officer at Nordberg Medical, says,
“Achieving the MDR and MDSAP certification is an important milestone for us. It demonstrates our commitment to patient safety, product quality and operational excellence, while further building the trust our clients and partners place in us every day. These certifications also provide an important foundation for the continued international development of JULÄINE. As we expand into new markets, maintaining these standards will remain central to how we grow.”