Medical electrical equipment—Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
€334.00
Healthcare technology management (HTM) educational programs Corrigendum 1
This product is not for sale, please contact us for more information
Cybersecurity considerations unique to machine learning–enabled medical devices
€178.00
Biological evaluation of medical devices—Part 2: Animal welfare requirements
€144.00
Safety and effectiveness of health IT software and systems—Part 3: Application of risk management
€21.00
U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
€311.00
Systems used to forecast remaining pacemaker battery service life
€268.00
Signal averaging
€221.00
Acquisition and use of physiologic waveform databases for testing of medical devices
€251.00
Generating reports for the purpose of submitting defibrillation waveform data for evaluation
€126.00
Sustainability of medical devices—Elements of a responsible product life cycle
Medical device safety assurance case guidance
Risk management of radio-frequency wireless coexistence for medical devices and systems
Dialysis fluid chemical composition
Active implantable medical devices—Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators