CER PROVIDER SELECTION
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Medical device insights grounded in evidence and regulatory practice.
Practical analysis at the intersection of medical device regulation, clinical evidence, postmarket surveillance, and scientific communication.
FDA regulatory resource
Explore the IMTS FDA Reg-AdvisorA free educational resource for medical device professionals. Preview the interface; question answering is coming soon.
EU MDR EVIDENCE ALIGNMENT
How CER, PMS, PMCF, PSUR, and SSCP Must Remain Aligned Under EU MDR
A practical framework for controlling shared evidence, risks, conclusions, and postmarket commitments across the document lifecycle.Read the article
MEDICAL WRITING
Why We Still Need Medical Writers in the Age of AI?
Why expert judgment, evidence interpretation, authorship accountability, and strategic context remain essential in medical writing.Read the article
POST MARKET SURVEILLANCE
Enhancing Post Market Surveillance Through Electronic Health Records
A perspective on how electronic health records can strengthen postmarket evidence generation for medical devices.Read the article
WHITE PAPER WRITING
How to Write a Data Driven Visually Immersive White Paper
A practical look at combining credible evidence, narrative structure, and visual communication in a medical device white paper.Read the articleCLINICAL EVALUATION
Unpacking State of the Art for Clinical Evaluation Reports
How state-of-the-art evidence establishes the clinical context, benchmarks, alternatives, and acceptability criteria used in a CER.Read the articleCLINICAL EVALUATION
Do Not Miss These Key Points While Drafting a Clinical Evaluation Report
A practical checklist for connecting device scope, clinical benefits, evidence requirements, benchmarks, benefit risk, and complete CER conclusions.Read the articleDiscuss your evidence program
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IMTS supports medical device regulatory, clinical evidence, and scientific communication programs.