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Beyond EU MDR: Unleashing Opportunities to Innovate and Ensure Patient Safety

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Beyond EU MDR: Unleashing Opportunities to Innovate and Ensure Patient Safety     A harmonious blend of innovation and patient safety is paramount in today’s ever-evolving medical device regulatory landscape. Furthermore, sustainability of massive regulatory data, updates to the evolving regulations, adherence to country-specific requirements, and adoption of an intelligent yet cost-effective approach to reducing overhead …

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Automating Computer Systems Validation for Your QMS

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Automating Computer Systems Validation for Your QMS      Companies must show that their software systems are performing as expected to comply with regulatory requirements. All validation activities and test results must be documented to define both how the software is used and what the user needs to do with it. By using this documentation, we …

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Digitalizing Drug Delivery – What’s Next?

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Digitalizing Drug Delivery – What’s Next?     The market for connected drug delivery devices is rapidly expanding, with expectations the industry will grow by 9.1% annually until 2030.[i] Key factors driving market growth include an aging population increasingly suffering from chronic diseases and a shift towards treatment self-administration outside of a hospital setting. Connected devices …

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What You Need To Know About FDA Remote Medical Device Inspections

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What You Need To Know About FDA Remote Medical Device Inspections     Back in 2021, I wrote that FDA should have the authority to inspect medical device facilities remotely. This would allow FDA to check these facilities when in‑person inspections weren’t possible. The remote inspection argument was especially compelling in the throes of Covid-19, which …

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The Importance of High-Quality Communication in the Healthcare Setting

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The Importance of High-Quality Communication in the Healthcare Setting     According to a Commonwealth Fund Survey, more and more physicians are at risk of burnout and health systems globally are facing a primary care crisis[1] as well as staff shortages. These have been accelerated by the Covid-19 pandemic and worsened by budget cuts and an …

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Increasing Momentum in Medical Device Security

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Increasing Momentum in Medical Device Security     In 2021, an employee at Ireland’s public health and social services system—the Irish Health Services Executive (HSE)—opened a spreadsheet that was sent by email. The file contained malware. After two months of free access to the network, the attackers released ransomware into the system. As the BBC reports, …

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Blockchain Can Solve Pharma’s Costly Data Integrity Problem

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Blockchain Can Solve Pharma’s Costly Data Integrity Problem     In the pharmaceutical industry, quality data is the oil that keeps our systems running smoothly. In an increasingly digital world, the complexity of our data has grown exponentially, and, consequently, maintaining its integrity is an ever-growing concern. In fact, poor data quality costs companies $15 million …

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Facilitating Increased Digital Monitoring

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Facilitating Increased Digital Monitoring     Some years ago, a visit to a doctor’s office or to a traditional clinical trial setting involved securing a written assessment. That evolved to electronic health records (EHR), which allowed information to be sent to different outlets. In this scenario, the patient still had to physically go to the doctor. …

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Harnessing the Potential of LinkedIn for MedTech Professionals

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Harnessing the Potential of LinkedIn for MedTech Professionals     At some point since the start of the pandemic, a movement has been underway among seasoned professionals and experts across the life science sector. Sharing their expertise on LinkedIn has become a critical success factor, rather than a distraction. Nonetheless, LinkedIn is still a mystery for …

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The Turing Test is Dead

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The Turing Test is Dead     In May 2018, Google showcased a demo of Google Duplex, an AI-based technology that engages in real-world conversations to carry out simple tasks. The demo brought to mind some of Steve Jobs’ famous product keynotes, as Google Duplex was used to book a hair appointment over the phone with …

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