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161 resources

IMDRF/MDSAP WG/N6: Regulatory Authority Assessor Competence and Training Requirements

IMDRF Technical document 2021-10-20 IMDRF Documents

Technical document published 2021 by IMDRF.

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IMDRF/MDSAP WG/N4: Competence and Training Requirements for Auditing Organizations

IMDRF Technical document 2021-10-20 IMDRF Documents

Technical document published 2021 by IMDRF.

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IMDRF/MDSAP WG/N11: MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization

IMDRF Technical document 2021-10-20 IMDRF Documents

Technical document published 2021 by IMDRF.

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IMDRF/AIMD WG/N67 (Edition 1): Machine Learning-enabled Medical Devices: Key Terms and Definitions

IMDRF Technical document 2022-05-09 IMDRF Documents

Technical document published 2022 by IMDRF.

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IMDRF/Standards WG/N72 (Edition 1): IMDRF Standards Liaison Program Framework

IMDRF Information document 2022-05-13 IMDRF Documents

Information document published 2022 by IMDRF.

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IMDRF/PMD WG/N74: Personalized Medical Devices – Production Verification and Validation

IMDRF Technical document 2023-04-11 IMDRF Documents

Technical document published 2023 by IMDRF.

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IMDRF/CYBER WG/N70: Principles and Practices for the Cybersecurity of Legacy Medical Devices

IMDRF Technical document 2023-04-11 IMDRF Documents

Technical document published 2023 by IMDRF.

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IMDRF/CYBER WG/N73: Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity

IMDRF Technical document 2023-04-13 IMDRF Documents

Technical document published 2023 by IMDRF.

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IMDRF 23rd MC Meeting Brussels March 2023 – Outcome Statement

IMDRF Outcome statement 2023-04-21 IMDRF Documents

Outcome statement published 2023 by IMDRF.

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IMDRF/MC/N77: White Paper – 23rd IMDRF Session Joint Workshop by IMDRF – DITTA and GMTA on the importance of post-market related activities

IMDRF Information document 2023-04-24 IMDRF Documents

Information document published 2023 by IMDRF.

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