Medical Innovation Exchange

Compliance Management

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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Call for Abstracts: MedTech Regulatory Management Summit

Call for Abstracts: MedTech Regulatory Management Summit     The call for abstracts for the 2024 MedTech Regulatory Management Summit, hosted by Medtech Intelligence, is now open. The Summit, which will be held June 3-5, 2024, in Washington, DC, offers education, discussion and networking for the Medtech community as it works to develop processes, procedures and …

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Preparing for EU MDR Post Market Reporting

Preparing for EU MDR Post Market Reporting     EU MDR continues to pose challenges as companies prepare to recertify devices and bring new technologies to the European market. One of the big changes in the regulatory framework of EU MDR versus the current medical device directive (MDD) is the focus on post market surveillance (PMS) …

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Successful Development, Approval and Deployment of Digital Health Solutions

Successful Development, Approval and Deployment of Digital Health Solutions     For life sciences companies seeking to develop, deploy and successfully commercialize digital health products and solutions, the pathway to success can have many twists and turns, and be littered with false starts, roadblocks and more than a few misdirections. The pace of technological development—which is …

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