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Hi @ghadinehme 🤗
Niels here from the open-source team at Hugging Face. I discovered your work on Arxiv and was wondering whether you
would like to submit it to hf.co/papers to improve its discoverability. ...
NielsRogge
작업 내용
- 08_시판후_감시_PMS/SOP-FSCA-001_현장안전시정조치_절차.md 신규 작성 (v0.1)
주요 포함 사항
- EU MDR Art.87-92 / MDCG 2023-3 Rev.2 / EUDAMED MIR v7.3.1 반영
- FDA 21 CFR Part 806 Corrections Removals 절차 통합
- MFDS ...
documentation
review
github-actions[bot]
As a logged-in user, I want to comment on public worlds so that I can interact with other creators and give feedback.
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Could Have
CtrlAltKismet
PFactory v0.1 — Plan Factory
PFactory is the planning governance incubator in front of the execution agents: it ingests project plans, enriches them
with live org/cloud context, runs review gates, and ...
epic
pfactory
olafkfreund
개요
GUIDE-SQA-001 품질합의서 작성지침의 규제 간 정합성 및 기존 문서 연계 적합성을 검증하였습니다.
검증 결과
- 규제 간 정합성 (ISO 13485/FDA QMSR/EU MDR/MFDS): 전 항목 적합 (8/8)
- X-ray 특화 조항 검증: 전 항목 적합 (5/5)
- 기존 문서 연계 (개요/SOP-SUP-001/SOP-CC-001/SOP-DOC-001/SOP-RM-001/SOP-PMS-001): ...
Description: When using the Enatega Multivendor Customer App, a labeling issue has been identified in the navigation
flow. Upon pressing the Back icon, the label back is displayed along with the icon. ...
waleedahmedhere
개요
2026-05-17 일일 리서치 로그를 작성하였습니다.
리서치 주제
- ISO 13485:2016 §7.4 구매 프로세스 및 공급자 품질합의 요건
- FDA QMSR 전환에 따른 공급자 관리 영향
- EU MDR Art.10(9) 하도급 관리 의무
- X-ray 부품별 SQA 특화 요건 (튜브/디텍터/HV/SW)
- IEC 62304 ...
squellette de la classe et lecture du nombre de mouvement a réaliser
timy0139
개요
09_공급자_관리 카테고리에 GUIDE-SQA-001 품질합의서(SQA) 작성 지침 v0.1을 신규 작성하였습니다.
반영 내용
- ISO 13485:2016 §7.4 구매 프로세스 전반 요구사항 반영
- FDA QMSR (2024) §820.180(c) 폐지 → 감사 접근권 강화 반영
- EU MDR Art.10(9) 하도급 관리, Annex ...
개요
SOP-PKG-001 라벨링 및 포장 관리 절차의 규제 간 정합성 및 기존 문서 연계 적합성을 검증하였습니다.
검증 결과
- ISO 13485 vs FDA QMSR vs EU MDR vs MFDS vs IEC 60601-2-54: 전 항목 적합
- 기존 문서 연계(SOP-MFG-001, SOP-UDI-001, SOP-CC-001, SOP-DOC-001, ...
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Learn how you can use GitHub Issues to plan and track your work.
Save views for sprints, backlogs, teams, or releases. Rank, sort, and filter issues to suit the occasion. The possibilities are endless.Learn more about GitHub IssuesProTip! Restrict your search to the title by using the in:title qualifier.