Medical Device Academy, Inc.’s Post

📄 Navigate FDA and EMA eCTD requirements effortlessly with PDF publishing software! This advanced tool simplifies regulatory submissions by automating formatting, ensuring compliance, and streamlining validation processes. Reduce errors, enhance efficiency, and meet global standards for faster approvals. Whether for the FDA or EMA, PDF publishing solutions empower your team to focus on delivering quality over managing technical details. 🔗 Learn how these tools can transform your workflow: https://lnkd.in/gddCDkG5 #eCTDCompliance #RegulatoryPublishing #FDARegulations #EMAGuidelines #AutomationSolutions #PleasePublish

FDA: You did not provide enough information about your algorithm Solution A: Use clear diagrams like this one we use for all our submissions. Include the diagram key on every diagram. Solution B: Just hire us to do it :). We'll build it and FDA clear it.

📄 Navigate FDA and EMA eCTD requirements effortlessly with PDF publishing software! This advanced tool simplifies regulatory submissions by automating formatting, ensuring compliance, and streamlining validation processes. Reduce errors, enhance efficiency, and meet global standards for faster approvals. Whether for the FDA or EMA, PDF publishing solutions empower your team to focus on delivering quality over managing technical details. 🔗 Learn how these tools can transform your workflow: https://lnkd.in/gidxWEVb #eCTDCompliance #RegulatoryPublishing #FDARegulations #EMAGuidelines #AutomationSolutions #PleasePublish

The Shortcut to FDA Compliance: Streamlined Document Retrieval FDA compliance shouldn’t be a bottleneck. Yet, endless hours spent searching through guidance documents, regulations, and 510(k) summaries can hold your team back. With Complizen’s document retrieval feature, you get the resources you need in *seconds*, not days. Here’s how we make that happen: - Instant Access: No more manual searches; get the exact FDA documents you need with a click.  - Real-Time Updates: Stay aligned with the most current regulations and guidance.  - Focus on What Matters: Spend less time on paperwork and more time innovating. Ready to fast-track your FDA submissions? Discover how Complizen’s platform empowers you to streamline compliance and accelerate your path to market. https://www.complizen.ai/  #ComplianceEfficiency #FDARegulations #MedTechInnovation #complizen

Who would think that “Frankenstein” could denote a regulatory strategy! But yes, in a recent discussion with some high-profile consultants about a new 510k for a client, one of them stated that you can no longer “Frankenstein” predicates to match your device (or to come up with a new device) in a submission and hope to obtain clearance. What a great term and visual for an approach that historically was possible, but no longer garners favor at the FDA. In 2014, final 510k guidance discouraged the use of multiple or “split” predicates. Then in 2018, the FDA added further refinements including the expectation that companies use newer predicates (within last 10 years) that reflect current standards and performance. Hence today, one and in some cases two,  predicates are the norm and offer the best chance of success. The term was also used a while back in a post by Mark Duval, another expert regulatory consultant and well known “fireman” for his ability to rescue submissions in distress for clients. I experienced his skill firsthand in a submission crisis involving a 510k with 5 predicates. Mark used “Frankenstein” in the context of describing a submission that had become a monster (in trouble) and how to avoid these situations. Lots of great advice and learnings over the years!

Are you still struggling to prepare your content for your next submission? Why spend hours doing this using external desktop tools, when you can be doing this literally in just seconds with DocShifter? Whether you do that for 50 submissions a year, or 5000. Whether you do that for one or multiple health authorities: US FDA, HC, PMDA, EMA, Swissmedic, MHRA. What if you can create fully-compliant documents in just 3 clicks, from anywhere you store your content? Discover how 3-Click document compliance works and what it means for you. Looking forward to seeing you! 📍 More info about the session: https://lnkd.in/e5r2c4y2

It’s time to unveil some FDA Myths! Many long-held beliefs about the FDA are only partially accurate and tend to be preconceived notions of the FDA. Despite being a cornerstone of regulatory oversight, the FDA's authority isn't always well understood, and numerous myths and misconceptions circulate about it. Let's unveil the facts: 🔎 The FDA is prohibited from publishing reviews or letters to the Applicant regarding products that fail to receive approval. 🔎 The FDA doesn't initiate most recalls; it's often the manufacturer or distributor. 🔎 The FDA engages in discussions regarding its approval decisions with regulatory bodies worldwide, involving regular communication such as monthly teleconferences with international agencies. 🔎 FDA guidance does not carry the same legal weight as a final rule or regulation. While guidance provides valuable insights, it's crucial for companies to understand the distinction between guidance and mandatory regulations. 🔎 The FDA has no independent authority to bring suit against the manufacturer or distributor, relying on collaboration with the Department of Justice. This partnership underscores the interagency efforts to uphold public health and safety standards. Don't let misconceptions cloud your understanding of FDA regulations! Stay informed, vigilant, and empowered. To build an FDA inspection-ready #QMS, dive into our blog >> https://bit.ly/4dmlbq5 #Compliance #Audits #RegulatoryCompliance

🔍 Join ETQ's webinar to gain insights into overcoming quality compliance challenges in the life sciences and medical device industries. From 2021 to 2023, the top three FDA citations for medical devices were related to inadequate procedures, complaint handling, and nonconforming products. In this webinar, attendees will learn about: ✔️ Understanding compliance challenges and complexities, such as MedWatch, the FDA’s medical product safety reporting program ✔️ Leveraging an enterprise quality management system (EQMS) for best practices in navigating regulatory challenges and streamlining complaints management ✔️ Lessons learned for achieving successful compliance ➡️ Register today to gain invaluable insights and strategies for scaling operations while ensuring compliance: https://buff.ly/4e02loQ Featured speakers: Kimberly W. Angel Bruzos #QualityControl #MedicalDevice #RegulatoryCompliance #QualityAssurance #MedicalDeviceRegulation #QualityManagement #MedicalDeviceManufacturing

🔍 Join ETQ's webinar this coming Monday (June 24th!) to gain insights into overcoming #qualitycompliance challenges in the life sciences and medical device industries. From 2021 to 2023, the top three FDA citations for medical devices were related to inadequate procedures, complaint handling, and nonconforming products. In this webinar, attendees will learn about: ✔️ Understanding compliance challenges and complexities, such as MedWatch, the FDA’s medical product safety reporting program ✔️ Leveraging an enterprise quality management system (#EQMS) for best practices in navigating regulatory challenges and streamlining complaints management ✔️ Lessons learned for achieving successful compliance ➡️ Register here: https://buff.ly/4e02loQ 🌟 Featured speakers: Kimberly W. Mike Farrell #QualityControl #MedicalDevice #RegulatoryCompliance #QualityAssurance #MedicalDeviceRegulation #QualityManagement #MedicalDeviceManufacturing

"FDA’s LDT RULE: Steps to Prepare for Your FDA First Milestone Submission," is available On-Demand!! To learn more about this webinar and to watch now, visit Dark Daily Webinars! https://hubs.ly/Q02Z6Cz10