October 2024 News Letter

Welcome to out October 2024 news letter, here we share the latest medical device regulatory news from the EU, UK and the USA as well as updated or new medical device standards that have been issued.
Patient Guard Medical Device Regulatory news letter update October 2024.
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Introduction

Hello,

We are thrilled to present the latest edition of Patient Guard newsletter, your go-to source for the most current updates for medical device and in vitro diagnostic (IVD) regulations and standards.

Thank you for your continued trust and partnership. We hope you find this edition of our newsletter both informative and valuable. As always, we welcome your feedback and are here to support you in any way we can.

Kind regards,

The Patient Guard Team

Regulatory News - October 2024

EU

UK

USA

New & Updated Medical Device Standards - October 2024

  • ISO 8536-13:2024 –  Infusion equipment for medical use – Graduated flow regulators for single use with fluid contact

  • BS EN ISO 7199:2024 – Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)

  • BS EN IEC 61674:2024 – TC – Medical electrical equipment. Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging

  • BS EN IEC 60601-2-33:2024 – Medical electrical equipment – Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

Patient Guards Medical Device Consultancy services
QMSREGS.com Medical Device Quality Assurance Templates, ISO 13485

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