Expert guidance across pharma, biotech, and medical devices — stay ahead of industry trends and best practices.
Your app qualifies as a medical device. Learn what EU MDR means for clinical evidence, Agile development, ISO 13485, CE marking and ongoing compliance.
Read article
When does a wellness app become a medical device under the EU MDR? Explore intended purpose, software qualification, Rule 11 and common grey areas.
Read more
Discover why in-house data often falls short of IVDR clinical performance requirements for IVD software and how to choose the right study design.
Read more
Is your AI use inspection-ready? Explore six questions GMP inspectors may ask about AI governance, human oversight, model changes and validation.
Read more
Discover six common HPV assay validation mistakes, from sample selection and cut-off optimisation to population differences and platform changes.
Read more
Moving an FDA-cleared AI diagnostic to Europe? Learn what evidence transfers, what IVDR requires and how a gap assessment can guide CE marking.
Read more
Can one HPV clinical performance study support both IVDR and WHO Prequalification? Learn how to align requirements and avoid duplicate studies.
Read more
Explore the Meijer criteria for HPV assay validation, including clinical sensitivity, specificity, reproducibility and their role in IVDR and WHO PQ.
Read more
Discover six risks of using LLMs in GMP, from hallucinations and inconsistent outputs to data leakage, and how to manage them responsibly.
Read more
Annex 1 implementation does not end with your first CCS. Learn how to keep contamination control risk-based, current and inspection-ready.
Read more
Regulation (EU) 2025/1466 changes EU signal management and EudraVigilance monitoring. Learn what MAHs need to implement and document.
Read more
The new EU Variations Guidelines change classification, grouping, work-sharing and Type IA planning. Learn what this means for variations management.
Read more
AI is not prohibited in GMP environments. Learn how intended use, risk, human oversight and existing quality controls determine compliant AI use.
Read more
Risk class alone does not determine the clinical evidence needed for IVD software. Learn what should actually drive your IVDR evidence strategy.
Read more