Nordberg Medical has achieved EU Medical Device Regulation (MDR) certification for JULÄINE, its skin booster, alongside Medical Device Single Audit Program (MDSAP) certification for its quality management system.
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The MDR certification confirms JULÄINE meets the EU’s requirements for medical devices, with the framework placing increased emphasis on clinical evidence, risk management, traceability and post-market safety monitoring.
MDSAP certification extends Nordberg Medical’s quality management recognition across participating markets including the US, Canada, Australia, Brazil and Japan, supporting the company’s plans for international expansion.
The certifications provide a regulatory and quality foundation for the continued development and market expansion of JULÄINE as Nordberg Medical builds its presence across global aesthetics markets.
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