Compliance with Clarissa - 2024

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Download the latest information from our medical device compliance experts.

Machine Learning and Artificial Intelligence (AI) in Medical Devices: Webinar | Fact Sheet

Chemical Analysis for Biocompatibility Assessment of Medical Devices Draft Guidance for Industry

ENERGY STAR® Requirements for Medical Imaging Equipment

Creation of IEC 60601-1 4th Edition

IEC TS 60601-4-2

IEC 60601-1-2 Ed. 4.1 Overview of Requirements

FDA ASCA Program Q&A

Medical OEM Wireless Coexistence Testing

Biocompatibility Risk Assessment and Evaluation Plans

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** The Intertek legal entities that provide medical device management system certification services (including ISO 13485 and MDSAP) and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. Clients who have used other Intertek legal entities’ consulting services are not eligible to receive management system certification services or Notified Body services from Intertek.