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Johner-Institut

Product Development

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Overview

Biocompatibility - ISO 10993
Multiple socket-outlets on medical devices: The European medical device directive (MDD) defines minimum requirements that have to be met by medical device manufacturers. It also defines the conformity assessment procedures.
Computer-Based Modeling & Simulation: Computer-Based Modeling & Simulation: Not Just a Tool for Quicker Authorizations, simulation, computer-based modeling, medical technology
ISO 17664-Processing of Medical Devices: ISO 17664, Processing of Medical Devices, Processing of health care products , the medical device manufacturer, 17664, reprocessing, cleaning
Autonomous Systems: Autonomous Systems: 4 Advantages for Medical Device Manufacturers, Autonomous Systems, Specific risks from autonomous systems
Recycling and Disposal of Medical Devices: High-quality materials, Recycling and Disposal of Medical Devices, Biocompatible, Reusing materials, Recycling, disposal and refurbishment
IEC 60601-1-2: Medical device manufacturers who IEC 60601-1-2 applies to should be aware of the changes between the two editions of this standard. Learn more!
Why VDE-AR-E 2842-61 (Trustworthy AI Systems) Doesn’t Just Apply to Development: In VDE-AR-E 2842-61 the VDE has developed a whole family of standards for trustworthy autonomous/cognitive systems such as AI systems.
Cytotoxicity Testing According to EN ISO 10993-5: Cytotoxicity testing can be used to test a sample to determine how much it can damage, or even cause the death of, human cells.
Substance-Based Medical Devices: Anyone who produces substance-based medical devices, e.g., saline nasal sprays, cough syrups that soothe the mucous membranes, will face several challenges.