Medical Innovation Exchange

regulatory compliance

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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MRI Safety Testing:  Making Implants More Compatible with Magnetic Resonance Imaging

MRI Safety Testing:  Making Implants More Compatible with Magnetic Resonance Imaging     Magnetic resonance imaging (MRI) is key when it comes to diagnosing and treating complex injuries or diseases. For spinal injuries or degeneration or different types of cancer there is rarely any better way to diagnose. Problems that may lead to serious conditions can …

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FDA Announces Expansion of Total Product Life Cycle Advisory Program Pilot

FDA Announces Expansion of Total Product Life Cycle Advisory Program Pilot     Beginning October 1, 2023, the FDA’s Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot will expand to include the Office of Neurological and Physical Medicine Devices (OHT5). The FDA’s Center for Devices and Radiological Health (CDRH) developed the voluntary Total Product Life …

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FDA Announces Expansion of Total Product Life Cycle Advisory Program Pilot

FDA Announces Expansion of Total Product Life Cycle Advisory Program Pilot     Beginning October 1, 2023, the FDA’s Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot will expand to include Neurological and Physical Medicine Devices. The FDA’s Center for Devices and Radiological Health (CDRH) developed the voluntary Total Product Life Cycle (TPLC) Advisory Program …

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MedTech Regulatory Compliance: Join the Discussion and Expand Your Regulatory Networks

MedTech Regulatory Compliance: Join the Discussion and Expand Your Regulatory Networks     From cybsecurity to remote inspections, recalls and quality management, medical technology regulations are rapidly expanding. This increase in global regulatory demands has presented new challenges for regulatory affairs and intelligence teams. On May 16-17, The MedTech Regulatory Intelligence Summit will bring together regulatory …

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Call for Abstracts: MedTech Advanced Manufacturing and Supply Chain

Call for Abstracts: MedTech Advanced Manufacturing and Supply Chain     MedTech Intelligence and Axendia are requesting abstracts for content to be presented during our upcoming Advanced Manufacturing Conference and Medtech Supply Chain Intelligence Summit. Both conferences will take place in November 2023 in Washington, DC. All abstracts will be judged based on the educational value. …

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Selecting a Resilient Medical Device Contract Manufacturer for Long-term Success

Selecting a Resilient Medical Device Contract Manufacturer for Long-term Success     Finding a resilient medical device contract manufacturer (CM) ensures a consistent supply chain, regulatory compliance, and long-term business success. Whether you are a Fortune 500 company or an early-stage startup, you will benefit from taking the time to find a CM partner who can …

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FDA Seeks Input on Advancing Use of Real-World Data and Evidence

FDA Seeks Input on Advancing Use of Real-World Data and Evidence     The FDA is seeking input from stakeholders on how it should use user fee funding for engaging with external organizations, other than the National Evaluation System for Health Technology (NEST), to support premarket Real-World Evidence. Under the fifth reauthorization of the Medical Device …

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MedTech Intelligence Announces 2023 Conference Series

MedTech Intelligence Announces 2023 Conference Series     Since 2010, MedTech Intelligence has produced valuable in-person conferences, and after three years of webinars, we are thrilled to bring back our in-person conference series to Washington, DC. The conference location brings in many high-level speakers from industry and FDA. Attendees can take advantage of networking opportunities, presentations …

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