Medical Innovation Exchange

Topic – Regulatory & Quality Intelligence

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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Role of Clinical Evaluation Report Consultants

Role of Clinical Evaluation Report Consultants     In the dynamic landscape of medical device regulations, ensuring the safety and efficacy of healthcare products is of utmost importance. One of the critical aspects of this process is the clinical evaluation of medical devices. A well-written Clinical Evaluation Report (CER) is vital for demonstrating the device’s safety …

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510k Submission Planning

510k Submission Planning     With an aim to provide thoughtful insight on how to go about planning a 510(k) submission long before the writing begins, we have created this helpful list of top tips, where we will outline the items you should be aware of when planning your 510K submission. Tip #1: Visit the FDA …

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