IVD equipment testing: software & electrical safety

The IVDR dramatically raises the importance attached to software. Many devices previously treated as self-declared products now fall into a much higher safety class, which greatly expands the role of Notified Bodies. A brief overview of the new requirements in relation to software is provided, covering aspects including general safety and performance requirements, technical documentation and classification.

The technical requirements of the IEC 61010-2-101 may be very complex to understand. Our experts will therefore give a short overview of these requirements as well as information on deviations in international standards including NRTL and IEC.

Date and time: Thursday, 5 November 2020, 6:30 pm (CET)

Your speaker: Dr. Alexander Stock, Lead Auditor and Martin Heinrich


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