各地域のユーザビリティエンジニアリング関連規制対応を支援いたします
米国FDAのHFEガイダンスに基づくヒューマンファクターエンジニアリングや、IEC/JIS T 62366-1に基づくユーザビリティエンジニアリング等、対応する規格やガイダンスに応じたプロセスを支援します。
- ヒューマンファクター/ユーザビリティ規制対応支援
- 現実的且つ最適なプロセスのご提案
- 必要な活動のご提案
主に対応する規格やガイダンス
IEC 62366-1:2015+AMD1:2020 CSV—Medical devices—Part 1: Application of usability engineering to medical devices (Consolidated version).
IEC TR 62366-2:2016—Medical devices—Part 2: Guidance on the application of usability engineering to medical devices.
JIS T 62366-1: 2022 – 医療機器―第１部：ユーザビリティエンジニアリングの医療機器への適用 Medical devices — Part 1: Application of usability engineering to medical devices.
U.S. FDA. (2016, February). Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff.
U.S. FDA. (2022, December). Content of Human Factors Information in Medical Device Marketing Submissions – Draft Guidance for Industry and Food and Drug Administration Staff.
U.S. FDA. (2023, September). Application of Human Factors Engineering Principles for Combination Products: Questions and Answers Guidance for Industry and FDA Staff.
U.K. MHRA. (2017, September 19). Guidance on applying human factors and usability engineering to medical devices including drug-device combination products in Great Britain.
China NMPA. (2024). Guidelines for the review of usability engineering for medical devices [医疗器械可用性工程注册审查指导原则].
