General Safety & Performance Requirements (GSPR)

Page	Covers
GSPR Overview	Annex I structure, three chapters, harmonised standards, demonstrating compliance
GSPR Checklist Approach	Compliance matrix structure, gap analysis, standards mapping
Software as a Medical Device (SaMD)	Qualification (MDCG 2019-11), IEC 62304, AI/ML in Switzerland
Cybersecurity Requirements	IEC 81001-5-1, MDCG 2019-16, pre- and post-market obligations

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