Life Sciences News and Resources
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
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FDA Moves into Oversight for Current, Future Robotic Surgical Systems
The FDA’s Center for Devices and Radiological Health has issued a draft guidance for robotically ass... -
FDA Moves Decisively on Alternatives to Animal Testing
The FDA announced Sept. 21 that it has issued a direct final rule to amend the language found in reg... -
FDA’s Device Center Leans in on Regulatory Reliance
The FDA’s Center for Devices and Radiological Health (CDRH) has opened a webpage to facilitate indus... -
PTO Considering Disclosure Mandate for Ex Parte Reexaminations
The U.S. Patent and Trademark Office (PTO) has proposed to require that petitions for reexamination ... -
IMDRF Posts Guidance for Predetermined Change Control Plans
The International Medical Device Regulators Forum (IMDRF) has posted a guidancefor predetermined cha... -
FDA Seeks Feedback on Oversight of Generative Artificial Intelligence
The FDA has posted a request for information (RFI) for the use of generative artificial intelligence... -
CMS Releases RAPID Proposal for Medicare Device Coverage
The Centers for Medicare & Medicaid Services has posted a draft version of the Regulatory Alignm...
