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Compliance In Focus


Newest Post

Posted by John Lehmann on Wed, Mar 04, 2015

Laying the Regulatory Groundwork for a Successful Physician-Sponsored IDE Study

Please take time to review IMARC Research’s new whitepaper entitled “Conducting a Physician-Sponsored Investigational Device Exemption -  Laying the Regulatory Groundwork for Success.”  When a Sponsor-Investigator conducts a device study, it may be referred to as a Physician-Sponsored IDE (PS-IDE).

Topics: IMARC Research Whitepaper, Regulatory, Physician-Sponsored IDE Study, PS-IDE

Posted by John Lehmann on Wed, Mar 04, 2015

China’s Proposed Regulations on Medical Devices - What Should American Device Companies Know?

March proved to be a busy month for China and the government bodies responsible for regulating food and drug safety.

Topics: Medical Devices, China, Regulatory

Clinical Research Training Requirements
Featured Resource

clinical research Training requirements

This whitepaper examines the similarities and differences between various US and international regulations and place them within the context of any number of roles found within the realm of clinical research.