Medical Innovation Exchange

FDA CDRH

FDA Elevates Office of Strategic Partnerships and Technology Innovation to CDRH Super Office

FDA Elevates Office of Strategic Partnerships and Technology Innovation to CDRH Super Office     As part of its reorganization of the Center for Devices and Radiological Health (CDRH), the FDA has elevated the Office of Strategic Partnerships and Technology Innovation (OST) to a Super Office within CDRH. Launched in 2019, the OST was designed create …

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Mitigating Supply Chain Risks

Mitigating Supply Chain Risks     On November 8-9, members of the Medtech community will gather in Washington, DC, for the MedTech Supply Chain Intelligence Summit. Hear from industry leaders and join in the discussion as we highlight strategies for overcoming current challenges and preparing for future supply chain risks. Learn how your peers assess and …

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Expand Your Regulatory Intelligence

Expand Your Regulatory Intelligence     In an increasingly digital world, medical device regulators and regulatory professionals have more information than ever to help them identify adverse events and new indications. Combined with shifting U.S. and global regulatory requirements, the task of staying abreast of new requirements and data sources is becoming a Herculean task. On …

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New Resource Sheds Light on FDA CDRH Regulatory Focus

New Resource Sheds Light on FDA CDRH Regulatory Focus     Device developers seeking insight into the current thinking of the FDA Center for Devices and Radiological Health as well as those pursuing a career in regulatory affairs have a new resource available. Elijah Wreh, Professor of Regulatory Science and Senior Manager Regulatory Affairs at Boston …

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How Real-World Evidence Helps Medical Device Manufacturers Drive Value

How Real-World Evidence Helps Medical Device Manufacturers Drive Value     Real-world evidence (RWE) captured during the testing phase for medical devices and during the post-approval period helps key stakeholders understand the clinical outcomes that can be achieved by using a particular device—including by population. RWE also offers important opportunities to ensure medical devices are used …

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