ISO 13485 certification doesn't cover QMSR. FDA's updated QMS regulation adds two sections your notified body never audits: §820.35 (records control) and §820.45 (labeling). Here's where the gaps are and what to fix before an inspector finds them.
Article 62, 74, or 82? A practical walk-through of MDCG 2021-6 Rev. 1, the decision tree, the documentation, and the timelines that decide whether your clinical investigation lands in regulatory good standing or stalls before first patient in.
What the new Cloud Computing Compliance Criteria Catalogue means for your next audit, and how to prepare before the June 2027 deadline.
Explore the hidden costs of MDR and IVDR compliance in the MedTech industry. Learn how certification, maintenance, re-certification, and operational challenges are impacting businesses, and discover strategies to stay ahead of rising costs.
CertHub's Jira integration syncs developer requirements directly into MDR, IVDR, and IEC 62304 technical documentation, closing the gap between engineering and regulatory teams without manual copy-paste.
The EU Commission published COM(2025) 1023 to reform MDR/IVDR. Six key changes for SMEs: Rule 11 software reclassification, no more 5-year certificate cap, standardized NB timelines, simpler equivalence, orphan/breakthrough pathways, and AI Act simplification.
A step-by-step guide to assigning UDI identifiers, registering in EUDAMED, and staying compliant with Regulation (EU) 2017/745.
CertHub, Modelwise, and FAU have launched TED-MeD, a research project funded by €956,832 to help MedTech SMEs streamline development and compliance. With an AI assistant and process model, the project aims to speed up certification and bring safer devices to market faster.
For many small and mid-sized medical device manufacturers, MDR compliance looks manageable on paper. The regulation is structured. The annexes are defined. The expectations of Notified Bodies are documented.
Compliance teams want to work with agents in the tools they already use. We've made that possible two ways, one keeps your data inside the EU, the other lets you bring ChatGPT, Copilot, or Claude to your workspace in about a minute. Here's how to choose.
