DNV_medical
DNV has 2 trusted Notified Bodies under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). DNV Product Assurance AS & DNV MEDCERT
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Simplified Chinese |
Simplified Chinese |
Korean | 의료기기 인증 MEDICAL DEVICE CERTIFICATION
Korean | 의료기기 인증 MEDICAL DEVICE CERTIFICATION
English | Medical device certification brochure
English | Medical device certification brochure
This brochure provides an overview of DNV’s medical device certification and regulatory services worldwide, including MDR, IVDR, ISO 13485, MDSAP, and TCP III. It highlights how DNV supports manufacturers in ensuring safety, compliance, and trust across the entire medical device lifecycle.
Our services
IVDR Certification | Trusted Notified Body for IVD Devices
IVDR Certification | Trusted Notified Body for IVD Devices
Achieve IVDR compliance with DNV. Our Notified Body experts help IVD manufacturers navigate EU regulation with speed, trust, and precision.
IVDR 인증 – 유럽 시장 진입을 위한 체외진단의료기기 규정 (IVDR) 대응
IVDR 인증 – 유럽 시장 진입을 위한 체외진단의료기기 규정 (IVDR) 대응
유럽 인증기관(DNV)의 전문 지원을 통해 IVDR 적합성을 확보하고, 인증 리스크를 줄이세요. DNV는 신뢰받는 Notified Body로서 제조업체의 성공적인 시장 진입을 지원합니다.
DNV欧盟公告机构IVDR认证服务（NB 2460）
DNV欧盟公告机构IVDR认证服务（NB 2460）
通过DNV获得体外诊断器械的欧盟市场准入资格。DNV是欧盟《体外诊断医疗器械法规》（IVDR - EU 2017/746）指定的公告机构。
MDR Certification | EU market access for medical devices
MDR Certification | EU market access for medical devices
Partner with DNV to navigate the EU MDR framework confidently. As a trusted Notified Body, we deliver reliable certification and expert support to help medical device manufacturers meet EU regulatory requirements.
Medical Device Single Audit Program (MDSAP)
Medical Device Single Audit Program (MDSAP)
Achieve faster, more efficient market entry with DNV’s Medical Device Single Audit Program (MDSAP) certification. Simplify compliance across multiple jurisdictions.
ISO 13485 | Quality management for medical devices
ISO 13485 | Quality management for medical devices
Achieve global market access and regulatory compliance with confidence through DNV’s ISO 13485 certification services for medical device quality management systems.
Website | Explore medical device certification services
Website | Explore medical device certification services
DNV provides medical device certification and compliance services, ensuring quality, safety, and regulatory approval for global market access.
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DNV 공식블로그 - BA & SCPA Korea : 네이버 블로그
DNV 공식블로그 - BA & SCPA Korea : 네이버 블로그
Follow us on LinkedIn | DNV - Life Sciences
Follow us on LinkedIn | DNV - Life Sciences
DNV - Life Sciences | 15,536 followers on LinkedIn. | DNV provides assurance across the Life Sciences value chain through certification, accreditation, and digitally enabled solutions. As a trusted independent partner, we help organizations navigate complex regulatory landscapes and evolving standards in medical devices, healthcare, and ocean health. Our focus is on enabling customers to gain market access, differentiate, and build resilience while safeguarding patient safety and protecting aquatic ecosystems.
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