QA/RA Consulting, Auditing & Training
Why FDA Inspections Feel Different Under QMSR: Part I Are you anticipating an FDA inspection in the near future? Things have changed under the new QMSR. In this blog post we discuss what you can now expect when FDA inspectors come calling. 1. The rules didn’t radically change but the lens FDA uses absolutely did […]
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QMSR Is Taking the Spotlight, But MDSAP Still Deserves Attention Why does MDSAP still deserve attention? Because “we’ve aligned to QMSR” and “we’re ready for MDSAP” are not the same thing. At some point in a lot of QMSR transition efforts, things start to feel pretty good. Processes have been updated. Risk-based thinking is getting […]
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ISO 9001 Is Changing Again – Here’s What Quality Leaders Should Be Watching Now ISO 9001 has always aimed to reflect how organizations actually operate, rather than how a quality system looks on paper. That philosophy isn’t changing, but the world we operate in certainly is. As we move toward the next major revision (targeted […]
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The EU MDR Is Not Being Weakened ├óΓé¼ΓÇ£ It├óΓé¼Γäós Being Reengineered: Why the Commission├óΓé¼Γäós 2025 Proposal Marks a Strategic Reset, Not a Rollback After four turbulent years of MDR implementation, on December 16, 2025, the European Commission reached a rare conclusion: Europe does not suffer from insufficient regulation ├óΓé¼ΓÇ£ it suffers from insufficient proportionality. From […]
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Elevate Your Medical Device Expertise: Spanish-Language Virtual Courses Tailored for LATAM As Latin America cements its role as a global hub for medical device manufacturing and exports, staying ahead of evolving quality, regulatory, and risk expectations has never been more critical. Whether you├óΓé¼Γäóre in Mexico├óΓé¼Γäós dynamic border clusters, Costa Rica├óΓé¼Γäós thriving OEM ecosystem, or Argentina├óΓé¼Γäós […]
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Costa Rica: Quietly Becoming the MedTech MVP (and Smart About It Too) While the global spotlight often shines elsewhere, Costa Rica has been efficiently building itself into a serious player in medical device manufacturing. It turns out that a focus on skilled labor, decent infrastructure, and a government that actually gets it can get you […]
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