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Author: Governance Docs

Governance Docs LLC

UK GDPR vs EU GDPR — UK GDPR vs EU GDPR: The 11 Differences That Matter in 2026

UK GDPR vs EU GDPR: The 11 Differences That Matter in 2026

Governance Docs13th September 2026

UK GDPR vs EU GDPR in 2026: lawful bases, rights time limits, automated decisions, transfers, complaints, age of…
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Data (Use and Access) Act 2025 — Data (Use and Access) Act 2025: Every Data Protection Change, Dated

Data (Use and Access) Act 2025: Every Data Protection Change, Dated

Governance Docs13th September 2026

Data (Use and Access) Act 2025 summary: each amendment to the UK GDPR, the DPA 2018 and PECR,…
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UK GDPR — UK GDPR: The Complete 2026 Guide After the Data (Use and Access) Act

UK GDPR: The Complete 2026 Guide After the Data (Use and Access) Act

Governance Docs13th September 2026

UK GDPR explained for 2026: the three statutes, who enforces it, the Data (Use and Access) Act 2025…
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IEC 62304 risk management — IEC 62304 Risk Management: How Clause 7 Fits ISO 14971:2019 (Clear 2026 Guide)

IEC 62304 Risk Management: How Clause 7 Fits ISO 14971:2019 (Clear 2026 Guide)

Governance Docs13th September 2026

IEC 62304 risk management explained: clause 7 as the software slice of ISO 14971:2019, the five cause categories,…
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IEC 62304 documentation requirements — IEC 62304 Documentation Requirements: Every Deliverable by Class (Clear 2026 Guide)

IEC 62304 Documentation Requirements: Every Deliverable by Class (Clear 2026 Guide)

Governance Docs13th September 2026

IEC 62304 documentation requirements in one table: every deliverable the standard names, the class at which each is…
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IEC 62304 FDA guidance — IEC 62304 FDA Guidance: Documentation Levels vs Safety Classes, Mapped (Clear 2026 Guide)

IEC 62304 FDA Guidance: Documentation Levels vs Safety Classes, Mapped (Clear 2026 Guide)

Governance Docs13th September 2026

IEC 62304 FDA guidance explained: why Documentation Level is not software safety class, how each element of the…
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IEC 62304 legacy software — IEC 62304 Legacy Software: The Clause 4.4 Route Explained Step by Step (Clear 2026 Guide)

IEC 62304 Legacy Software: The Clause 4.4 Route Explained Step by Step (Clear 2026 Guide)

Governance Docs13th September 2026

IEC 62304 legacy software under clause 4.4: who qualifies, the four-step route, the gap analysis scoped to 5.2,…
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IEC 62304 Edition 2 — IEC 62304 Edition 2: Release Date, What Changes and What To Do Now (Clear 2026 Update)

IEC 62304 Edition 2: Release Date, What Changes and What To Do Now (Clear 2026 Update)

Governance Docs13th September 2026

IEC 62304 Edition 2 status, September 2026: committee-draft stage, publication not before 2028, what the draft changes, and…
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IEC 62304 SOUP — IEC 62304 SOUP: What Counts and What You Owe at Every Class (Clear 2026 Guide)

IEC 62304 SOUP: What Counts and What You Owe at Every Class (Clear 2026 Guide)

Governance Docs13th September 2026

IEC 62304 SOUP explained: what counts as software of unknown provenance, the identification and maintenance duties every class…
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IEC 62304 vs IEC 82304-1 — IEC 62304 vs IEC 82304-1: Which Standard Does SaMD Need? (Complete 2026 Comparison)

IEC 62304 vs IEC 82304-1: Which Standard Does SaMD Need? (Complete 2026 Comparison)

Governance Docs13th September 2026

IEC 62304 vs IEC 82304-1 for software-only medical devices: one governs the software life cycle, the other the…
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IEC 62304 vs ISO 13485 — IEC 62304 vs ISO 13485: How the Two Standards Fit Together (Clause-by-Clause, 2026)

IEC 62304 vs ISO 13485: How the Two Standards Fit Together (Clause-by-Clause, 2026)

Governance Docs13th September 2026

IEC 62304 vs ISO 13485: one is the QMS, the other the software life cycle inside it. Clause-by-clause…
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IEC 62304 software safety classification — IEC 62304 Software Safety Classification: Class A, B and C Explained (2026 Guide)

IEC 62304 Software Safety Classification: Class A, B and C Explained (2026 Guide)

Governance Docs13th September 2026

IEC 62304 software safety classification explained: how Class A, B and C are decided, the Class C default,…
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