Medical Device Academy, Inc.’s Post

🌸 MDR clinical investigations 🌸 The 🆕 guidance on clinical investigations contains detailed descriptions about the contents of an Investigator's Brochure (IB), which is required to be included in MDR compliant clinical investigation applications. https://lnkd.in/dGgKZEAS #Medicaldevices #Clinical #Data #Regulatory #Requirements #EuropeanUnion

We know Brexit seems like a lifetime ago, but the issues it's raised around the supply of medicinal products to Northern Ireland is still a hot topic. Which is where the Windsor Framework comes in! Our team joined the MHRA's Windsor Framework Industry Webinar to see how the upcoming changes affect pharma clients, and find out what companies need to do to meet regulations across the UK. Here are our top takeaways: - Have 1st January 2025 circled in your diary! That's the date when all Windsor Framework changes come into force 📅 - After 1st Jan, a 'UK only' label MUST be on all new packs. It can be placed anywhere on the outer packaging, as long as it's legible. You can also add a sticker to comply, but only up until 30th June ❗ - Product licences (PLNI and PLGB) can't coexist for the same product after 1st Jan. The MA holder needs to request a withdrawal of the PLNI by 30th September – the PLGB will automatically convert to UK-wide on 1st Jan. If you miss the deadline, the MHRA will cancel your PLGB on 31 December! ❌ Find out more about the Windsor Framework: https://lnkd.in/eyFhHDtc

This is where Software/SaaS can really add value providing real time data and access to data: Quote: When it comes to CRO and CDMO partnerships, biotechs find the most value in data access and regulatory expertise" What Biotechs Want from CRO and CDMO Partnerships Free Survey Report (tradepub.com)

So proud of my colleagues Patterson (Pat) Shafer and Cheryl Tan who helped author Drug Information Association's new ebook on regulatory information management (RIM). If you’re curious about expert strategies for improving regulatory performance in pharma and medical devices, you can download your copy here: https://lnkd.in/gJFCNEyA Way to go, #TeamFTI!

Get Ahead of the Curve: 2025 Compliance Readiness Starts Now 🌟 The regulatory landscape is evolving fast, and 2025 is just around the corner. Is your company prepared to meet new compliance standards? At RQM+, we specialize in helping businesses navigate complex regulatory challenges. From FDA to MDR/IVDR and ISO transitions, we have the expertise to ensure you're ready for what's next. What we offer: - Regulatory submission support - Quality management system updates - Audit preparation and gap assessments - Post-market surveillance strategies - Specialty projects such as managing the changes with PFAS Don't wait until the last minute. Start preparing today to secure your compliance tomorrow. Contact RQM+ now and let's build your roadmap to 2025 readiness! 🔗 https://lnkd.in/e7wxN59w #Compliance #RegulatoryAffairs #QualityAssurance #MedicalDevices #IVDR #MDR #FDA #ISO13485 #RQMPlus

Is it a surprise that HCPs dislike filling out forms to download peer-reviewed scientific content, even if it's just their name and email? Probably not. Would it lead to drop-off? Yes, most likely. So why send out licenced ePrint content in a way that requires form filling when it can be avoided? To access published content, certain details like name and email are necessary. However, whether through email, at congress, or any other channel, the need to fill in a form can be removed by using Trustrack, offering HCPs a better experience with your brand, and achieving the best click-through rate as a result. Download our Trustrack flyer here (no form filling, we promise!) >> https://lnkd.in/gkgUAugQ

It’s critically important for as many medical website providers as possible to recognize the risks and understand that delivering medical information is, above all, a matter of patient safety. We may never know how many lives have been endangered because readers relied on inaccurate information from a website. It’s essential to understand that providing incorrect medical information can result in serious adverse outcomes.

So proud of my colleagues Patterson (Pat) Shafer and Cheryl Tan who helped author Drug Information Association's new ebook on regulatory information management (RIM). If you’re curious about expert strategies for improving regulatory performance in pharma and medical devices, you can download your copy here: https://lnkd.in/gCUbchVz Way to go, #TeamFTI!

Navigating complex regulations in the medical industry can be overwhelming, but it doesn’t have to be! Our latest eBook, "The Medical Device Regulatory Survival Guide", breaks down the steps to streamline compliance with standards like ISO 13485 and 21 CFR regulations, helping you save time and focus on what matters—innovation and patient care. Check it out to learn how to simplify your processes and boost efficiency >> https://lnkd.in/eDNhmxR4

So proud of my colleagues Patterson (Pat) Shafer and Cheryl Tan who helped author Drug Information Association's new ebook on regulatory information management (RIM). If you’re curious about expert strategies for improving regulatory performance in pharma and medical devices, you can download your copy here: https://lnkd.in/eZg-2Agm Way to go, #TeamFTI!