Online Medical Devices Quality & Regulatory Affairs Training
Comply Guru is offering online (on-demand), virtual & blended Medical Devices (Quality Assurance & Regulatory Affairs) Training Courses including ISO 13485:2016, European Medical Device Regulations (EU-MDR & EU-IVDR), Risk & ISO 14971:2019, MDSAP & more.
ISO 13485:2016 is a Quality Management System Standard which outlines the requirements for regulatory purposes. These requirements are intended to be applicable to any medical device organisation regardless of size and activity as a basis for demonstrating and supporting compliance with applicable regulatory requirements.
The European Medical Device Regulation (MDR) is a set of regulations that must be met if producing or distributing medical devices within the EU, and if you want to sell your Medical Devices in the EU.
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