Medical devices
Medical devices are subject to strict regulatory processes to enter the market. Manufacturers need to show compliance with the corresponding requirements and standards which needs to be certified by an independent organization. DNV has two certification and notified bodies which offer a wide range of services to suit your needs – DNV Product Assurance and DNV MEDCERT.
Medical devices
Services
Combined audits for medical device certification
ISO 13485 certification - Quality management for medical devices
IVDR Certification for EU Market Access
Malaysia MDA medical device conformity assessment and registration support
MDR Certification: EU market access for medical devices
Medical Device Single Audit Program (MDSAP) – Global Market Access
TCP III Certification: Market Access in Taiwan
Transfer medical device certification to DNV
The new medical device regulations (PDF)
What does it mean for manufacturers?