Not every gap is cute and closes on its own. You may call us the tooth fairy, but we prefer to rely on our years of expertise instead of fairy dust. 🧚🏻♀️💫 Because even though the IVDR transition deadlines got a little extra time, it doesn't mean your open issues will magically solve themselves. What should you do? 🤔 Use our gap analysis for IVD software and you are guaranteed to be prepared for all upcoming challenges. Find out more about our range of services for IVD manufacturers here: https://lnkd.in/egwgEhBg
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Navigating regulatory hurdles in medical device supply chains can be daunting. Our upcoming webinar on September 12 is designed to provide you with the tools and knowledge you need to overcome these challenges. Join industry experts Jon Ewert and Amanda Crawford as they share their extensive experience and practical strategies. Register now to ensure you’re equipped to tackle these issues head-on → https://buff.ly/3z84BL2
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Even if you have a mature process for complaint handling, LDT final rule will require an adjustment by your team to perform "product centric" investigations.
The FDA’s new regulations for LDTs are fast approaching, with strict deadlines that could impact your laboratory’s operations if not met. This webinar offers detailed guidance to help you understand these new rules and implement necessary changes efficiently. STAGE 1 (Effective May 6, 2025): Focuses on establishing foundational compliance with Medical Device Reporting (MDR), correction, and removal reporting, and managing complaint files. Our industry experts, who conduct this webinar, have first-hand experience helping laboratories prepare and comply with the new regulations. Register Today! https://bit.ly/4hrBxzJ Can't make the date? We'll send a watch on-demand link.
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FDAnews DeviceWeekly is a #FREE weekly publication will help you keep track of important global regulatory, legislative & business news developments in the medical device industry. Scan major headlines in few minutes and know what you need for the day. Free daily headlines can be found at FDAnews.com. Get it here https://lnkd.in/e3Ss3KXi and receive FDAnews Device Weekly each Wednesday. #FDA #MedicalDevice
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We are excited to attend the FDA/AdvaMed Medical Device Statistical Issues Conference in DC. It’s a pleasure to connect and discuss the design, use, and methodological best practices of developing regulatory statistics to understand the safety and performance of therapeutic and diagnostic devices. The success of these analyses is based, in part, on the strength of the data used to inform the analyses. Contact us if you would like to learn more about our robust de-identified RWD clinical data set and the extensive medical device data that can be linked to inform those types of analyses. https://lnkd.in/e_Fzi_4q #HealthcareStatistics #MedicalDevices #MedicalTechnology
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It's #483 week! Follow along to learn tips and tricks for responding to a 483 😀
HAPPY 483 WEEK! 😁 We know 483s are anything but happy, but they are an unfortunate reality in our industry. FDA issued 720 483s to medical device establishments in FY2023, a 34% increase from FY2022 😬 So what do you do if you receive a 483? Every day this week we’re sharing a tip for formulating the best 483 response to decrease ⏬ your likelihood of receiving a subsequent Warning Letter. Without further adieu… Tip 1️⃣ ! It is 𝒏𝒐𝒕 sufficient to simply open a CAPA to address an observation or group of similar observations. The CAPA must progress through the CAPA process as much as possible, with 𝐫𝐞𝐜𝐨𝐫𝐝𝐬 𝐨𝐟 𝐭𝐡𝐞 𝐩𝐫𝐨𝐠𝐫𝐞𝐬𝐬𝐢𝐨𝐧 being provided to FDA in follow-up 483 responses. Additionally, any implemented changes (and we’ll talk about what “implementation” means tomorrow 😉) must be 𝘷𝘦𝘳𝘪𝘧𝘪𝘦𝘥 𝘧𝘰𝘳 𝘦𝘧𝘧𝘦𝘤𝘵𝘪𝘷𝘦𝘯𝘦𝘴𝘴, and records of the VOE must also be furnished to FDA. If you can’t wait to read the remaining tips, or want to see examples, click the link to read our Insights article ⏩ https://lnkd.in/gdxVhgqj Please also feel free to share any tips or tricks that you’ve found helpful in the comments below! #fda #483week #warningletter
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Navigating the complex world of regulatory compliance and testing protocols for your medical device? Discover three powerful strategies that can help you define the best regimen: https://bit.ly/3LzXZZv
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Visit our team of experts at booth H-169 today and learn how our services could benefit your business succeed. We are aware of the challenges the medical device industry faces as a result of regulatory limitations. We've created specific regulatory plans as a result to assist you in expanding your global market reach. #Hospitalar2024 #Medicaldevice #RegulatoryChallenges #Regulatoryaffairs #MeetOurExperts #Event
Visit our team of experts at booth H-169 today and learn how our services could benefit your business succeed. We are aware of the challenges the medical device industry faces as a result of regulatory limitations. We've created specific regulatory plans as a result to assist you in expanding your global market reach. #Hospitalar2024 #Medicaldevice #RegulatoryChallenges #Regulatoryaffairs #MeetOurExperts #Event
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📢 EUDAMED’s mandatory implementation deadline has moved up to Q1 2026 (previously Q2 2029)! 💡 Watch USDM's Jay Crowley and BAYARD's Lionel Tussau in this webinar, where they outline essential steps medical device manufacturers need to take to stay compliant with the new regulations. ✅ Watch the webinar here: https://bit.ly/4eBA8ow
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Visit our team of experts at booth H-169 today and learn how our services could benefit your business succeed. We are aware of the challenges the medical device industry faces as a result of regulatory limitations. We've created specific regulatory plans as a result to assist you in expanding your global market reach. #Hospitalar2024 #Medicaldevice #RegulatoryChallenges #Regulatoryaffairs #MeetOurExperts #Event
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A great post by Hyman, Phelps & McNamara, P.C. on the dynamics between industry and FDA. Let's just say that you can never, ever be careful enough about how you manage that relationship. And if you need help, I'm here to guide you!
