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Life sciences news and resources
Life Sciences News and Resources
For Entrepreneurs
Medmarc supports Innovators who drive progress in life sciences technologies. Resources for Start-ups, R&D stage companies, and those preparing to Commercialize.
Risk Management
Resources designed to help you identify and prevent products liability exposures, our publications, webinars, and industry-specific articles.
Clinical Trials
Resources for Companies conducting Human Clinical Trials: Informed Consents, Ethics and Institutional Review Boards, Introduction to Products Liability, Global Clinical Trials.
blog.medmarc.com
Medmarc provides in depth discussions regarding current risk management and products liability issues in this life sciences industry blog.
Latest Medtech and Life Sciences Resources
FDA Stands Its Ground on CDS Guidance
Jan 08, 2025
The FDA’s guidance for clinical decision support (CDS) programs has proven unusually controversial, ...
FDA Finalizes Guidance for AI Predetermined Change Control Plans
Dec 26, 2024
The FDA has published the final version of a guidance for predetermined change control plans (PCCPs)...
FDA Appoints New Director for Center for Devices
Nov 12, 2024
The FDA has appointed a new director for the Center for Devices and Radiological Health (CDRH) to re...
Mammography False Positives Endanger Screening Compliance
Nov 01, 2024
A new study published recently in the Annals of Internal Medicine disclosed an association between f...
Navigating the FDA Rule on IRB Waivers for Minimal Risk Trials: Pt. 2 – Products Liability Concerns and the Role of Informed Consent
Sep 16, 2024
This post is the second in a series that examines the products liability risks associated with the F...
CMS Issues Final Policy For Breakthrough Device Coverage
Aug 30, 2024
The Centers for Medicare & Medicaid Services has delivered its final policy for the Transitional...
Navigating FDA Rule Changes for Minimal Risk Trials: Implications & Best Practices
Aug 21, 2024
The recent FDA rule change regarding Institutional Review Board (IRB) waivers for minimal risk clini...