Blog, page 2
Notes from our consultants on regulatory, clinical, quality, validation, IT and staffing topics.
QMSR is in effect: what the first weeks look like
FDA’s ISO 13485-aligned device regulation took effect on 2 February 2026. Early observations from manufacturers and inspections.
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Vakula Connect, Q4 2025: Ninety days to the QMSR
Our Q4 2025 update for consultants and clients: market signals, the roles in demand, and what was new at Vakula Technologies Inc.
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QMSR is ninety days away: a readiness checklist
With FDA’s Quality Management System Regulation effective 2 February 2026, here is what device manufacturers should have finished by now.
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E6(R3) takes effect in Europe; FDA finalises Computer Software Assurance
Two transitions landed in the third quarter of 2025: GCP R3 became applicable in the EU and FDA completed its CSA guidance.
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Vakula Connect, Q3 2025: E6(R3) in effect; CSA finalised
Our Q3 2025 update for consultants and clients: market signals, the roles in demand, and what was new at Vakula Technologies Inc.
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Vakula Connect, Q2 2025: Preparing for E6(R3) in Europe and QMSR in the US
Our Q2 2025 update for consultants and clients: market signals, the roles in demand, and what was new at Vakula Technologies Inc.
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The LDT rule is vacated: what laboratories should do now
A federal court set aside FDA’s laboratory developed test rule on 31 March 2025. The compliance programme should not simply be discarded.
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Vakula Connect, Q1 2025: E6(R3) adopted; AI guidance; LDT rule vacated
Our Q1 2025 update for consultants and clients: market signals, the roles in demand, and what was new at Vakula Technologies Inc.
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January 2025: ICH E6(R3) adopted; FDA issues draft guidance on AI in regulatory decisions
Two documents in the first month of 2025 set expectations for clinical trial conduct and for the use of AI models in submissions.
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