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Health
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4 knowledge bases in Health
Clear filters- HealthVerified: Official sources reviewed and answers tested by Kopik
Surgical robots & medical device software: FDA regulatory pathways and guidance
Covers FDA's regulatory pathways for robotically-assisted surgical devices (RASD) and the software inside them: 510(k) and De Novo classification, premarket software documentation levels, premarket cybersecurity, human factors and usability testing, AI-enabled device software functions and Predetermined Change Control Plans (PCCP), SaMD clinical evaluation, post-market Medical Device Reporting, and the Quality Management System Regulation (QMSR) aligned with ISO 13485. Built for regulatory affairs managers at medtech companies, robotics startups and clinical engineers who need article-level, citable answers rather than a general overview; it is not individualized regulatory advice, and two included FDA guidances (RASD premarket submissions, AI-enabled device lifecycle management) are still drafts, not final. Curated by Kopik from public sources: U.S. Food and Drug Administration and eCFR (U.S. government works, public domain).
15 documents, 0 questions asked
- Health
UK workplace health and safety: HSE guidance for employers
Official Health and Safety Executive guidance for UK employers: managing for health and safety (HSG65), work-related stress and the Management Standards, display screen equipment, manual handling, first aid, COSHH, work at height and RIDDOR reporting. General workplace-health information for managers and H&S leads, not individual medical advice. Curated by Kopik from public sources: Health and Safety Executive (OGL v3).
8 documents, 0 questions asked
- Health
Heat, cold and health: UKHSA guidance for organisations
UK Health Security Agency guidance on protecting public health during hot and cold weather: the Adverse Weather and Health Plan and its evidence base, heat-health alert action cards for health and social care, advice for schools and early years, mass gatherings and events, and cold-weather support for vulnerable people. For care, education, event and local-authority professionals. Curated by Kopik from public sources: UK Health Security Agency, GOV.UK (OGL v3).
8 documents, 0 questions asked
- Health
Santé et sécurité au travail : les obligations de l'employeur
Les règles de prévention des risques professionnels en entreprise : document unique (DUERP), aménagement des lieux de travail, accidents du travail, fortes chaleurs, compte professionnel de prévention (C2P), passeport de prévention et aides à la prévention. Pour employeurs, RH et préventeurs ; information générale, pas de conseil médical. Base éditée par Kopik à partir de sources publiques : Service Public Entreprendre, DILA (Licence Ouverte 2.0).
8 documents, 0 questions asked
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