{{ phone }} {{ location }}

Emergo by UL logo

         

medical device clinical investigation

良好临床实践(GCP)在医疗器械临床研究中的作用

EMERGO BY UL关键点摘要:

  • 进行产品临床研究的医疗器械公司必须遵守良好临床实践(Good Clinical Practice, GCP)。
  • GCP要求向独立医疗器械软件(SaMD)提供了一些例外,部分开发商可能有资格享受这些例外。
  • 除GCP外,ISO 14155等其他标准可能适用于医疗器械的临床研究。

医療機器治験における医薬品の臨床試験の実施の基準(Good Clinical Practice :GCP)の役割

EMERGO BY UL キーポイントのまとめ:

  • 自社製品の臨床調査を実施している医療機器会社は、医薬品の治験の実施の基準(Good Clinical Practice :GCP)を遵守しなければなりません。
  • GCP 要件は、医療機器ソフトウェア(SaMD)には例外を設けており、一部の開発業者が有資格かもしれません。
  • GCP の他にも、ISO 14155 などの追加基準が医療機器のための治験研究に適用される可能性があります。

The Role of Good Clinical Practices (GCP) in Medical Device Clinical Investigations

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Good Clinical Practice (GCP) must be adhered to by medical device companies conducting clinical investigations for their products.
  • GCP requirements make exceptions for software as a medical device (SaMD) for which some developers may qualify.
  • Besides GCP, additional standards such as ISO 14155 may apply to clinical studies for medical devices.

Aperçu de la troisième édition d'ISO 14155 : Rôle de la gestion du risque dans les investigations cliniques

Par Stewart Eisenhart

LES POINTS PRINCIPAUX PAR EMERGO by UL :

  • La mise à jour prévue de la norme ISO 14155 en 2019 comprend des exigences plus strictes en matière de gestion des risques cliniques.
  • Cette troisième édition de la norme ISO 14155 sur les essais cliniques des dispositifs médicaux s'alignera plus étroitement sur les concepts de gestion des risques des dispositifs médicaux de la norme ISO 14971.
  • Les principes de gestion de la qualité appliqués aux audits d'investigations cliniques sont également introduits dans cette dernière édition de la norme ISO 14155.

ISO 14155 제 3판 미리보기: 임상 연구에서 위험 관리의 역할

이머고 핵심 요약:

  • 2019년 예정된 ISO 14155로의 업데이트는 임상 위험 관리에 대한 더 강력한 요구사항을 포함합니다.
  • ISO 14155 의료기기 임상 연구 기준의 제 3판은 ISO 14971 의료기기 위험 관리 개념을 더욱 엄중하게 조정할 것입니다.
  • 임상 연구 심사에 적용된 품질 관리 원리도 ISO 14155의 최신 판에 도입됩니다.

ISO 14155 Third Edition Preview: Role of Risk Management in Clinical Investigations

EMERGO SUMMARY OF KEY POINTS:

  • The anticipated update to ISO 14155 in 2019 includes stronger requirements for clinical risk management.
  • The third edition of the ISO 14155 medical device clinical investigation standard will align more closely to ISO 14971 medical device risk management concepts.
  • Quality management principles applied to clinical investigation audits are also introduced in ISO 14155’s latest edition.

ISO 14155 Update in 2019: Key Changes for Medical Device Clinical Investigations

EMERGO by UL SUMMARY OF KEY POINTS:

  • The third edition of the ISO 14155 standard for medical device clinical investigations is expected in 2019.
  • Broader risk management requirements are a key feature of the revised ISO 14155.
  • Final publication of ISO 14155’s third edition will likely occur in mid-2019.