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

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

Regulatory News from ☄️Switzerland: Make sure to examine the clarification provided on new requirements for products without an intended medical purpose. 👇Subscribe now to read the full story: https://lnkd.in/dUiFxgap #medicaldevices #medizinprodukte #dispositivosmedicos #dispositifsmedicaux #dispositivimedici #regulatoryaffairs

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

Dive into Post-Marketing Medical Device Reporting essentials with #Soterius. From 21 CFR PART 803 to EMA Regulation 2017/745, we unravel key requirements for safeguarding health. Join the regulatory conversation now @ https://bit.ly/49wcszs #ComplianceInsights #MedicalDevices #RegulatoryCompliance

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

Wondering how to respond to the #notifiedbody audit findings? Or how to select a notified body for a notified body opinion process? Join us for a morning coffee ☕ at Medicon Valley Alliance and find answers to these questions; We look forward seeing you in Copenhagen! Check below details for the event and register 👇 #regulatorycompliance #medicaldevices #IVD #DDC #NBO #pharmalex Piritta Maunu, Torben Thers Nørgaard