Quadax, Inc.的动态

Europe just enacted new requirements for device manufacturers to report anticipated product supply disruptions, and FDA wants the US Congress to follow suit. #medtech #medicaldevices #productsupply

Take a look at this great article focusing on the benefits of a tool-based approach to traceability! #medicaldevice #mdr #ivdr

The #FDA has issued the long-awaited final rule on the regulation of laboratory-developed tests (LDTs) as medical devices. What comes next? Join us for a webinar exploring the potential impacts if the rule goes into effect, political response and other critical implications. #LDTs

??Turn regulatory challenge into competitive advantage ?? Karl Johan Larsson explains how by adopting traceability tools: ??https://lnkd.in/dK_zj9ft ? Elevate your expertise and stay connected with the latest trends and best practices in Medical Device Development. ? #traceability #medicaldevices #regulatory

The medical device landscape is evolving fast, that’s for sure. For?manufacturers of medical devices, keeping track of the regulations is a challenge, but crucial for bringing and keeping solutions on the market safely and efficiently. But have no fear, our experts are on top of this! At Archer, we’re committed to navigating you through the latest regulatory updates for Medical Devices in Europe. ??In this #AskArcher update, we’re answering the question: “How will the new Regulation (EU) 2024/1860 accelerate the roll out of EUDAMED and how to be prepared?” ? Read the answer in the blogpost on our website ?https://lnkd.in/eTumjD-w #medicaldevices #expertCRO #compliance #medtech #archerresearch

Current challenges in Europe's medical device market include the #EUMDR transition, a shrinking pool of notified bodies, and a lack of harmonization. Device manufacturers, regulators, and other stakeholders can take these key actions to create positive change in 2025 and beyond, writes Marcelo Trevino in this new Med Device Online article. https://lnkd.in/euEyTkzr #medicaldevicedevelopment #regulatory

Hey everyone, it’s Darren again with another DP Minute. Today, we're unpacking Comment No. 62 from the QMSR preamble. This one is straightforward but important! In this comment, a suggestion was made that the FDA should delete the phrase "immediately before use" from section 820.45, which deals with packaging and labeling. The concern was that this phrase adds a new and unnecessary burden on manufacturers. Check out the video to hear more about this discussion and the FDA’s response. Our DP Minutes are designed to help you navigate the complexities of medical device regulations. Have questions or want to dive deeper? Visit DPDConline.com for more insights, and connect with us on LinkedIn to join the conversation. #QMSR #ISO13485 #FDA #MedicalDevices #DPDConsulting #MedicalDeviceRegulatoryConsulting #Packaging #Labeling #DPDC

Very helpful summary of the planned roll out of EUDAMED! Make sure to scroll down to the bottom for a clear timeline on where we are and what is planned to come in the next years ?? #mustread #medicaldevices #eudamed #archerresearch #askarcher

?? Stay Ahead in MedTech with Apotech's Latest Quality and Regulatory Insights! Our November newsletter is packed with updates and insights to keep you informed on the latest global regulatory changes impacting the medical device industry. From post-market surveillance to AI-enabled devices, these developments could shape the future of compliance and innovation. ?? Join us at the RQA Conference in Brighton this week (6-8 Nov) — Stop by Stand 26 to connect with our team and learn more about our services! Follow us or reach out at contact@apotechconsulting.com to stay informed. #MedTech #MedicalDevices #RegulatoryUpdates #Apotech #RQA2024 #Innovation

?? Regulatory Update video for India! In today’s update, we are going to give you a regulatory wrap-up in India that will include the following information: Advertising of Medical Devices. ?? Visit https://hubs.ly/Q034cVRg0 to: 1. Watch the FULL YouTube regulatory update video, 2. Subscribe to our channel, and 3. Sign up for regulatory update notifications! Never miss an important update again. #ArazyGroup #RegulatoryUpdate #RegulatoryAffairs #RegulatoryGuidelines?#RegTech #RegTechAI