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  1. Courses
  2. Medical Device
  3. Specific-Active Devices
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Use of Laser Devices in the Medical Field
Clinical Evaluation of Artificial Intelligence Products
The Effect of Ambient Air Pressure on Active Medical Devices
S1. General requirements for basic safety and essential performance-IEC 60601-1
S2. Software & Cybersecurity, life-cycle processes, conjunction with ISO 14971 based on conformity assessment approach, EN 62304
S3. Usability Engineering: conjunction with ISO 14971 based on conformity assessment approach, EN 62366
 MDR conformity assessment activities  for active medical devices-Experience Sharing
S17. Machinery Directive: Regulation (EU) 2023/1230, based on conformity assessment approach
Devices for cleaning, disinfection and sterilisation
S41. Active non-implantable devices (and imaging device) utilizing radiation, health effects and protective measures, quality control, safety and efficacy requirements based on conformity assessment, specific standards and guidelines
S42. Medical patient monitors-Vital and non vital physiological parameters
Medical patient stimulators, quality control, safety and efficay requirements based on conformity assessment approach, specific standards and guidelines
Extracorporeal circulation devices, administration or removal of substances and haemapheresis
Respiratory Devices
S46. Active wound care devices, quality control, safety and efficacy requirements for conformity assessment, specific standards and guidelines
S47. Ophthalmologic Devices
S48. Active ENT device, quality control, safety and efficacy requirements for conformity assessment, specific standards and guidelines
Dental Devices
Gas supply systems, quality control, safety and efficacy requirements for conformity assessment, specific standards and guidelines
S51. Functional safety of electrical/electronic/programmable electronic safety related systems-IEC 61508
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Data retention summary
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