BSI BIP 0113:2012

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Guide to European medical device trials and BS EN ISO 14155

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BSI BIP 0113:2012

Guide to European medical device trials and BS EN ISO 14155

PUBLISH DATE 2012
PAGES 104
BSI BIP 0113:2012

Guide to European Medical Device Trials and BS EN ISO 14155

This guide provides comprehensive information on conducting clinical investigations for medical devices in Europe, ensuring compliance with regulatory requirements. It outlines the essential principles and responsibilities involved in the trial process.

Key aspects covered include:

  • Understanding the regulatory framework governing medical device trials in Europe.
  • Implementation of the BS EN ISO 14155 standard, which specifies good clinical practice (GCP) for designing, conducting, recording, and reporting clinical investigations.
  • Ensuring patient safety and data integrity throughout the trial.
  • Roles and responsibilities of sponsors, investigators, and ethics committees.
  • Documentation and reporting requirements.

By adhering to this guide, stakeholders can effectively navigate the complexities of clinical investigations, maintain compliance, and support the development of safe and effective medical devices.

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