SZUTEST ACADEMY: Tüm kurslar

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

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