ISO 14971 and EU MDR: Integrating Risk Management with Clinical Evaluation
Summary Most manufacturers have a risk management file. Far fewer have a risk management process that stays current, connects meaningfully to clinical…
11 Sep 2026
PSUR vs PMSR: Understanding Post-Market Surveillance Reporting Under EU MDR
Summary Under EU MDR 2017/745, post-market surveillance is no longer a passive requirement. It is an active, continuous process of collecting, analysing,…
01 Sep 2026
CiteMed Evidence Cloud V6.0.6: Post Market Surveillance Software Release That Closes the Loop
Summary Altus, released in May 2026, made every stage of CiteMed Evidence Cloud faster. AI screening got a visible reasoning trail, PDF…
18 Aug 2026
CiteMed Evidence Cloud Altus: Software for Literature Review That Works the Way Regulatory Teams Actually Work
Summary Finding software for literature review that genuinely works in a regulated medical device environment is harder than it should be. Most…
24 Jul 2026
PRISMA and EU MDR Literature Review: A Guide to Structured Evidence Methodology
How PRISMA Principles Support Transparent and Defensible Medical Device Literature Reviews Literature reviews play an increasingly important role in demonstrating the safety…
15 Jul 2026
How to Conduct an EU MDR Literature Review: A Step-by-Step Guide to Submission-Ready Evidence
Applying PRISMA Principles to Meet MEDDEV 2.7/1 Rev 4 and Annex XIV Requirements Starting an EU MDR literature review can feel overwhelming.…
03 Jul 2026
How Medical Writers Should Use AI in Automated Literature Review Without Compromising Regulatory Defensibility
AI-Powered Literature Review for Medical Writers: Balancing Efficiency with Scientific Oversight Introduction AI-powered literature review tools are becoming a standard part of…
16 Jun 2026
Why Mendeley and Citation Managers Are Not Enough for EU MDR Literature Review
Mendeley and Reference Management Software: Why They Fall Short for EU MDR Clinical Evaluation Introduction The use of reference management software and…
03 Jun 2026
How Long Does a Medical Device Literature Review Take Under EU MDR?
Medical Device Literature Review Timelines: What Really Determines How Long It Takes As regulatory expectations continue to evolve, literature review has become…
29 May 2026