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We are proud to announce the transition of JULÄINE™ to the MDR certification, affirming our compliance with the elevated European standards for medical devices.
Committed to excellence
The certification is a testament to Nordberg Medical’s scientific foundation, commitment to patient safety and dedication to driving innovation in aesthetics and beyond.
“Achieving the MDR 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."
Sílvia Alexandra Fernandes, Chief Regulatory Affairs Officer, Nordberg Medical
MDR Certification: A new benchmark
The European Union’s Medical Device Regulation (MDR) replaces the earlier Medical Device Directive (MDD) by introducing a more rigorous framework. The new regulation imposes higher requirements for clinical evidence, safety, traceability, and continuous surveillance.
The transition to MDR certification demonstrates JULÄINE™’s conformity with the EU’s regulatory standards and supports its commercialization across European markets. It further strengthens the industry’s trust in Nordberg Medical as a reliable partner positioned for international expansion. For aesthetic professionals, it brings an even greater sense of confidence and reassurance when using JULÄINE™ of Sweden.
Nordberg Medical has also obtained Medical Device Single Audit Program (MDSAP) certification, signifying that the company has passed a quality-system audit accepted by major national authorities, including the US, Canada, Australia, Brazil, and Japan. The achievement streamlines approval pathways in these key international markets.
Quality standards and foundations
Our production adheres to ISO 13485:2016, the international standard for medical devices. This standard is also central to MDR and MDSAP certification. MDR compliance relies on standards such as ISO 13485 for the quality management system, while MDSAP audits combine ISO 13485 with specific requirements of participating countries.
Partner with us
With market approval in more than 35 countries, we continue to expand access to JULÄINE™ worldwide. For partnerships and market enquiries, please get in touch with our team here.
We are proud to announce the transition of JULÄINE™ to the MDR certification, affirming our compliance with the elevated European standards for medical devices.
Committed to excellence
The certification is a testament to Nordberg Medical’s scientific foundation, commitment to patient safety and dedication to driving innovation in aesthetics and beyond.
“Achieving the MDR 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."
Sílvia Alexandra Fernandes, Chief Regulatory Affairs Officer, Nordberg Medical
MDR Certification: A new benchmark
The European Union’s Medical Device Regulation (MDR) replaces the earlier Medical Device Directive (MDD) by introducing a more rigorous framework. The new regulation imposes higher requirements for clinical evidence, safety, traceability, and continuous surveillance.
The transition to MDR certification demonstrates JULÄINE™’s conformity with the EU’s regulatory standards and supports its commercialization across European markets. It further strengthens the industry’s trust in Nordberg Medical as a reliable partner positioned for international expansion. For aesthetic professionals, it brings an even greater sense of confidence and reassurance when using JULÄINE™ of Sweden.
Nordberg Medical has also obtained Medical Device Single Audit Program (MDSAP) certification, signifying that the company has passed a quality-system audit accepted by major national authorities, including the US, Canada, Australia, Brazil, and Japan. The achievement streamlines approval pathways in these key international markets.
Quality standards and foundations
Our production adheres to ISO 13485:2016, the international standard for medical devices. This standard is also central to MDR and MDSAP certification. MDR compliance relies on standards such as ISO 13485 for the quality management system, while MDSAP audits combine ISO 13485 with specific requirements of participating countries.
Partner with us
With market approval in more than 35 countries, we continue to expand access to JULÄINE™ worldwide. For partnerships and market enquiries, please get in touch with our team here.
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