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QMSR 2026: A Practical Compliance and Inspection Guide (From People Who’ve Lived Through Regulatory Change)
QMSR 2026 took effect Feb 2. What actually changed, the ISO 13485 myth, the 80/20 of compliance, and how FDA now inspects under CP 7382.850.
FDA QMSRQMSR 2026: What every FDA-registered firm must do in the next 12 months
FDA's Quality Management System Regulation replaces 21 CFR Part 820 on 2 February 2026, harmonising with ISO 13485:2016. The transition is not cosmetic — here is the playbook.
EU MDREU MDR Extension 2023/607: strategic implications for legacy device holders
The amendment extended legacy MDD certificates — but Notified Body capacity and PMS obligations remain a binding constraint. A strategy memo for sponsors.
AI in MedTechFDA’s PCCP for AI/ML SaMD: A comprehensive implementation guide
Predetermined Change Control Plans let you pre-authorise AI/ML modifications. We unpack the FDA 2023 guidance with a real-world example.
LATAMANVISA + COFEPRIS in parallel: a LATAM medtech registration playbook
Brazil and Mexico together account for 65% of LATAM medtech spend. Registering them in parallel is achievable — here is how.
StartupsThe regulatory strategy your Series A investors actually want to see
Most startup decks treat regulatory as a checkbox. Sophisticated investors want a defensible pathway, risk-tiered timeline, and a credible team. Here is a template.
FDA QMSRFDA’s LDT Final Rule: Three strategic options for clinical laboratories
Phase-in begins 6 May 2025. Whether you stay LDT, file 510(k)/De Novo, or restructure, the time for analysis is now.
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