Medical devices
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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Robert Dostert
Sales Manager, Medical Devices
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Schedule a call with an expertISO 13485 – Medical devices quality management
Medical Devices Regulation (EU) 2017/745 - MDR
The new medical device regulations (PDF)
What does it mean for manufacturers?
Medical Devices Certification Requirements
Conditions and processes for certification
ISO 13485:2016 Medical Device Quality Management System Foundation Training
A must attend training course for those who will be auditing their own organization’s ISO 13485:2016 quality management system