Online & Blended Medical Devices Quality/Regulatory Training Courses
Comply Guru™ is offering online, virtual & blended Medical Devices (Quality Assurance & Regulatory Affairs) Training Courses including ISO 13485:2016, EU Medical Device Regulation (EU-MDR), 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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- ISO 9001
- ISO 13485
- EU MDR
- EU IVDR
- ISO 14971
- FDA QSR 21 CFR 820
- ISO 17025
- ISO 14001
- ISO 45001
- ISO 27001
- FSSC 22000
- Clinical Evaluation
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★★★★★ ( Reviews, Click to view)
This online course will offer an interactive overview of Clinical Data Evaluation for Medical Devices & MEDDEV 2.7/1.
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