Production of medical devices is a strictly regulated business. These products can be crucial in matters of life and death. In almost all countries, and for most medical products, there are requirements and standards to which manufacturers need to show compliance.
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DNV MEDCERT certification services
ISO 13485 – Medical devices quality management
Medical Devices Regulation (EU) 2017/745 - MDR
AI Medical Device Software Under the MDR
This white paper reviews some key aspects of safety and performance assessments of AI medical device software according to the existing regulation (EU) 2017/745 (MDR) ahead of the upcoming regulatory updates and standards publication.
Medical Devices Certification Requirements
Conditions and processes for certification
The new medical device regulations (PDF)
What does it mean for manufacturers?