Greenlight Guru

SaMD compliance in your dev tools https://bit.ly/3TyDoLi

MedDRA coding for adverse events https://bit.ly/4aLr4xn

Three CROs quote the same manufacturer this month. Similar credentials. Similar pricing. One gets the study. The medical device CRO market is growing close to 8% a year and is on track to hit $43.6 billion by 2035. Every CRO reading that stat sees opportunity. Fewer see the trap: more manufacturers outsourcing also means more CROs competing for the same shortlist, and a generalist pitch is the fastest way to lose it. The CROs winning that tiebreaker are doing three things. They cut study startup time by carrying eCRF templates and configurations across studies instead of rebuilding from scratch every time. They stay visible to manufacturers before the outsourcing decision is even made, so they are already known when the shortlist gets built. And they lead every proposal with a specific device class or regulatory pathway instead of a broad capability list, because "we can probably handle it" loses to "we have handled exactly this." None of it guarantees growth. It is the difference between a CRO that does good work for existing clients and one that keeps winning new ones at a cost of acquisition that makes sense. https://bit.ly/4wpYpWO

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A supplier causes your nonconformance and the audit finding still lands on you. That's the bind supplier driven CAPA (Corrective and Preventive Action) puts quality teams in: you're accountable for a fix you can't perform yourself. A Supplier Corrective Action Request (SCAR) is how you close that gap, but a weak one stalls, gets ignored, or leaves you exposed at your next audit. On July 29, Rook Quality Systems is hosting a live session on managing supplier corrective action when the process isn't in your hands. Kyle Rose (Rook Quality Systems) will be joined by our own Etienne Nichols to cover when a supplier issue warrants a SCAR versus an internal CAPA, how to write SCARs that actually get a response, verifying corrective action you can't perform yourself, and building supplier oversight that holds up under FDA and ISO 13485 scrutiny. Register here: https://lnkd.in/eEjqmpMQ #MedTech #QualityManagement #SupplierManagement

ISO 14155:2026 replaced the 2020 edition with no transition period. The changes are substantive and the standard is already in effect. Sponsor responsibilities moved to Clause 9, PI responsibilities to Clause 10. CECs are now formally governed for the first time. The estimand framework from ICH E9(R1) is now required for study design. AE categories have been restructured, and risk management obligations for device-related and procedure-related risks are now treated as distinct. We put together a section-by-section compliance checklist covering what sponsors and investigators need to have in place, from CIP preparation through study close-out. Pre-study and ongoing study requirements are separated so teams can use it as an operational reference, not just a document check. https://bit.ly/4vhxLym

Most teams treat "audit-ready" as something you sprint into during the two weeks before an inspection. Under QMSR, that math doesn't hold up anymore. FDA investigators can now pull internal audits, supplier audits, and management reviews, records that used to be off-limits, and they're testing whether your CAPA, complaint, and risk records actually connect to each other, not just whether each one exists on paper. MediBeacon went through three audits in six weeks, an internal audit, an EU MDR stage one audit, and a combined ISO 13485, MDSAP, and EU MDR audit, and passed all of them with zero major findings. Not because the team scrambled harder than everyone else. Because the records were already connected before the date landed on the calendar. We wrote up what daily audit-readiness actually looks like, and the habits that make the difference between a system that holds up and one that doesn't. https://bit.ly/4f1n6BM

A pharma EDC can run your device study. That is exactly the problem. Most medical device teams do not pick the wrong EDC. They inherit one. A CRO already knows a pharma-heritage platform, or an investor recommends it, and the study gets stood up on software designed for 3,000-patient drug trials. It captures data, so it looks fine. The mismatch shows up in three places: Setup time. Enterprise pharma platforms are implemented in quarters. A device team needs to enroll its first patients in weeks or months. Fees. You pay for scale, services, and configuration you will never use, just to make a general-purpose tool behave like a device tool. Control. Under ISO 14155 and EU MDR, you are responsible for your clinical evidence, even when a CRO runs the study. Too often that data ends up somewhere you cannot freely reach, in a format that is hard to export, right when a regulator asks for it two years later. "Configurable" is not the same as "ready." A device-built EDC ships with the study designs, eCRF and ePRO structures, and adverse event workflows device trials actually need, from first-in-human through PMCF. New on the blog: what you give up when your device study runs on a pharma EDC. #MedTech #ClinicalTrials #EDC #EUMDR #ClinicalData https://bit.ly/4eHIu05

Greenlight Guru has achieved ISO/IEC 42001:2023 certification for AI governance, covering its eQMS and EDC products. As the first medtech-focused QMS and EDC provider to achieve this certification, Greenlight Guru gives customers independently verified evidence they can use in supplier qualification, technical files, and audit responses, whether they're navigating FDA scrutiny or EU compliance obligations. "Every vendor in medtech is talking about AI," said Robin Sterzer, Director of Security and Compliance at Greenlight Guru. "The question our customers ask is whether they can trust what it produces when someone is in the room asking how a decision was made. This certification is independently verified proof that how we govern AI meets that bar." https://bit.ly/3SwWukP