Qualio’s Post

Registration is now open for the DistillerSR, AKRA TEAM, and 3Aware in-person #MedTech event on June 5 2024 at the Hyatt Centric Downtown Minneapolis. Here's why you should attend: 1️⃣ Learn the latest updates from the Medical Device Coordinating Group (MDCG) on clinical investigation guidance, including how these revisions impact the planning and conduct of clinical trials. 2️⃣ Hear firsthand experiences, key lessons, and practical insights from medical device manufacturers who have successfully navigated the #EU #MDR certification process. 3️⃣ Explore effective strategies for conducting literature searches, appraising relevant clinical data for #CER, #PER, and post-market surveillance, and adopting an enterprise evidence management strategy. 4️⃣ Discover how #RWE can support clinical claims, including the nuances and best practices for utilization across the US and EU markets. Register now, seats are limited: https://bit.ly/49IBKt9

We are pleased to share that InspireHealth NV will participate in the second edition of the CEO Round Table on March 20 in Leuven, an exclusive C-level event focused on the crucial discussion around Medical Device Regulation (MDR) and certification backlogs. This event, organized by MEDVIA, brings C-level leaders together from the healthcare industry for lunch and a round table discussion. The goal is to share experiences, propose solution-oriented ideas and engage in conversation with the guest speaker, Virginie Siloret, which is the Global Medical Devices Certification Manager at SGS. 🔍 The Topic: The challenges of MDR and certifications in Europe are significant, especially given the approaching expiration dates of CE markings and the current shortage of notified bodies. The discussion will focus on bridging the gap between these bodies, the medical device industry and market operators. Michiel Hertegonne will be present to represent InspireHealth NV at the event. We are looking forward to the interesting discussions! #medvia #ceoroundtable #innovation #certifications #medicaldeviceregulation

🛫 Our team is heading to RAPS Euro Convergence in 3 short days! If you will be in Berlin for this event, please stop by Booth B-6 to learn how RegDesk can optimize your regulatory process with our AI-powered RIM solution. Join us for a special session: Challenges Facing Medical Device Teams with Priya Paul (Bhutani) Learn how your team can accelerate your time to market and stay ahead of the growing complexity in Regulatory Compliance. May 7 from 1:00-1:30 in B05/B06 #RAPSEuroConvergence #RegDesk #RegulatoryAffairs #Berlin

The one thing you can always count on is - CHANGE. Change can create better efficiency, improved safety, and enhanced performance. I have used DistillerSR for many projects and I am always impressed by the functionality of the software. My colleague Justin has summarized his insights from the MedTech Event last month. Check it out! What do you think about AI and "human in the loop"?

Great collaboration and engaging discussions between Mads Koch Hansen and Lene Laursen at #MedicoIndustrien and #TÜVSÜD on the future of EU regulatory tracks for medical devices! 🚀🔬   We tackled key perspectives from both Notified Body (NB) and manufacturer sides, focusing on the EU Parliament’s short- and long-term regulatory strategies.   Key Takeaways:   🅰 Short-Term: What EU parliament is discussion is what NB2443 has proven its strength in delivering predictable and transparent pricing 💰, timelines ⏳, SME supported QMS infrastructure🤝, and capacity 📈 – a solid foundation for immediate needs. Client testimonials will follow shortly on LinkedIn - don't miss it - Start follow me on LinkedIn   🅱 Long-Term: The MDR must evolve to become "future-proof." This means:   Digitalization: Enabling seamless digital workflows for regulatory processes 💻. Clarity and Focus: Keeping the regulation clean by narrowing the scope strictly to product safety topics ✅.   As we look ahead, I’m particularly excited about the Danish Presidency of the Council of the EU in the second half of 2025 👏 . This presents a unique opportunity to collaborate with key Danish ministries and #MedicoIndustrien and drive a future where innovative medical devices are entering the European market first 🌍 . Together, we’re shaping a sustainable and innovative regulatory landscape for the benefit of manufacturers, Notified Bodies, and—most importantly—patients 💙.   #TUVSUD #MDR #Medicaldevices

AI is such an interesting topic with numerous applications in this field. I am very interested to see how it develops and changes the way we do things.

Achieving Big Results in Just 4 Months! One of the world’s top medical device manufacturers partnered with Cloudbyz and saw a 25% improvement in the consistency of their adverse event data—in just four months! Curious how we can help you achieve similar success? Book a personalized demo with us to explore how Cloudbyz can streamline your clinical operations and enhance data quality. And don’t forget—we’ll be at the World Drug Safety Congress in Amsterdam! Let’s connect in person to discuss how Cloudbyz can support your safety and compliance goals. 🔗 https://hubs.ly/Q02R_ctg0 #CustomerSuccess #BookADemo #Cloudbyz #DataExcellence #MedicalDevices #WorldDrugSafety

Know anyone that’s developing a medical device? Because they need to know about our 2024 MedTech Path to Market, True Quality Summit Series. (Listen, I didn't come up with the title... 😅) This is a free, 3-day event with 10+ sessions... The presenters include ex-FDA submission reviewers, product development engineers, and QA/RA professionals who've seen it all. (But don’t tell anyone, my favorite part is getting to chat with y’all...) And because it's my favorite part, we've decided to award prizes for the attendees that embody our values: True Quality, Fanatical Support, and Be Innovative (But Etienne, how are you going to determine who embodies those values ?) I'm still working on that part... So let me just reserve the right to change what the awards are for right now!! Let's use the format we’re used to for our kids birthday parties: 𝗪𝗵𝗮𝘁: Free 3-day virtual event where we simplify Quality Management, Design Controls, Risk Management, and Regulatory pathways. 𝗪𝗵𝗲𝗿𝗲: Wherever you are in the world that has an internet connection! 
 𝗪𝗵𝗲𝗻: August 6 - 8, 2024 𝗪𝗵𝘆: It’s more than great information - it’s a chance to interact with some of the greatest minds in MedTech and ask them questions that are relevant to what you're doing.
 Now you can save this post and not worry about remembering! (Hmm, unless you're like me and can never remember how to find saved LinkedIn posts...) You know what, I’m just gonna break the rules and give you the link: https://lnkd.in/gC9nzPZs 😅 If you know someone working in medical devices that this could benefit, feel free to share!. P.S Which one of GG's values is your favorite? (Be innovative, True Quality, Fanatical Support) Put it in the chat! 🙌

Achieving Big Results in Just 4 Months! One of the world’s top medical device manufacturers partnered with Cloudbyz and saw a 25% improvement in the consistency of their adverse event data—in just four months! Curious how we can help you achieve similar success? Book a personalized demo with us to explore how Cloudbyz can streamline your clinical operations and enhance data quality. And don’t forget—we’ll be at the World Drug Safety Congress in Amsterdam! Let’s connect in person to discuss how Cloudbyz can support your safety and compliance goals. 🔗 https://hubs.li/Q02R-MNL0 #CustomerSuccess #BookADemo #Cloudbyz #DataExcellence #MedicalDevices #WorldDrugSafety

👨💻 The medical device development journey can be unpredictable, especially with your first product. Engaging with the #FDA early on has helped us lower our regulatory risk. Leading the medical device submission, I've seen how free guidances and Pre-submission meetings speed up the VnV cycle. The Digital Medicine Society (#DiMe) gathered 10 use cases to share best practices, including our journey with Gabi SmartCare 🙌 . --> https://lnkd.in/eveKAg8Z