CertHub

We're proud to announce that CertHub is a founding member of SARA – Society for AI in Regulatory Affairs! AI is moving into Regulatory Affairs faster than the profession can agree on how to use it well. Where does it genuinely create value? Where does it introduce risk? And what does responsible, defensible AI use actually look like inside a regulated environment? These are the questions SARA exists to answer - together with Hoodin and MedTech Leading Voice, we're building an open space for RA professionals to work through them collectively: through webinars, round tables, articles and honest community discussion. Not hype. Not fear. Just a practical, experience-driven look at where AI belongs in Regulatory Affairs - and where it doesn't, yet. We're excited to help shape this from day one. Full introduction and how to join below. ↓ https://lnkd.in/eWhyZkSY #RegulatoryAffairs #AIinRegulatory #MedTech #Compliance #SARA #CertHub

👋 Welcome, Kay-Uwe Clemens👋 We set out to find someone who could bridge two worlds most people only understand one of: the regulatory reality of medical device manufacturers AND the practical application of AI. We found him in Kay-Uwe Clemens — who spent the last years successfully driving the digital transformation of Regulatory & Clinical Affairs at Carl Zeiss Meditec, turning RA into a strategic function through AI-driven workflows and process innovation. With his new role at CertHub Kay can apply his experience and learnings of using AI in regulatory affairs to other MedTech enterprises — showing what actually works in reality, and what doesn't! That's exactly what our customers need. Not theory. Not slides. Someone who's done it. Welcome to CertHub, Kay!. Let's build! #CertHub #MedTech #Compliance #AI #DigitalTransformation

Hardware. Software. Sterile disposable. Three product components. One regulatory challenge that multiplies everything. Mario Roser didn't just survive it, Elixion Medical got ISO 13485 + EU MDR certified on the very first attempt. Most startups don't. Watch the full story 👇 (Link in the comments)

Most MDR Technical Documentation today isn't a file. It's a federation. Polarion. DOORS. Word. SharePoint. eQMS. PDFs. The same product, the same requirements, spread across systems. On May 22, we're showing, live, in 60 minutes, what changes when QA/RA teams treat the TechDoc as one structured data model instead of a folder. What you'll actually see: → Legacy transfer: AI migration from your existing systems, without re-platforming → Change management: one product change updates every affected document and market record → Submission management: one source of truth across EU MDR/IVDR, FDA 510(k), MHRA, Swissmedic, ANVISA, Health Canada, TGA, IMDRF/MDSAP Plus AI Gap Analysis: see exactly where your TechDoc falls short of MDR/IVDR before your notified body does. Live demo + Q&A with Leon Kobinger (Managing Director & Co-Founder) and Nicolas Gehring (CTO & Co-Founder). (NEW DATE) Jun 11, 11:00 CEST. Free. Save your seat → https://lnkd.in/dUY2jrU2 Curious to hear from the QA/RA folks here: across how many systems does your active TechDoc currently live? Five? Ten? More? #MDR #IVDR #RegulatoryAffairs #MedTech #QualityManagement

Seats are filling up. If you’ve been thinking about joining our CE Mark webinar, this is your sign. We’re covering the full certification path from device concept to CE submission in one hour. Live demo included. Q&A at the end. 🗓 Tuesday, April 28 · 11:00–12:00 CEST 📍 Online via Microsoft Teams Sebastian Grömminger (Head of Regulatory & Quality) & Luca Salvatore (Head of Growth) will walk you through: → EU MDR & IVDR milestones → Where most teams lose time, and how to avoid it → Live technical file demo → Open Q&A. Last spots available. 👉 Register now: https://lnkd.in/d4pJnwXk

UDI compliance under EU MDR doesn't have to be confusing. With EUDAMED registration becoming mandatory on May 28, 2026, every medical device manufacturer needs a clear UDI strategy, now. But the rules are scattered across Article 27, Annex VI, and multiple MDCG guidance documents. That's why we put together a complete guide covering: → The 2-step process to determine if your device needs a UDI → Basic UDI-DI vs. UDI-DI vs. UDI-PI — what each one does and where it goes → When you need a NEW UDI-DI (model changes, sterility, software updates) vs. just updating the UDI-PI → SaMD-specific rules for conveying UDI through the user interface → Direct marking requirements for reusable devices → The 4 authorized issuing entities (GS1, HIBCC, ICCBBA, IFA) and how to choose → 2026–2027 EUDAMED deadlines you can't afford to miss We also created a visual Decision Tree you can download and keep as a quick reference for your team. Read the full article + download the infographic here: 🔗 https://lnkd.in/dWWPd8cX Still handling UDI manually? Speed up your EUDAMED transfers with automation. We have it! Let's talk → certhub.de #MedTech #EUMDR #UDI #MedicalDevices #RegulatoryAffairs #EUDAMED #ISO13485 #Compliance #QualityManagement #CertHub