Christian Pellevoisin, PhD, ERT’s Post

POV: you’re an RA person and hear the words ‘Reliance’ and ‘Convergence’ A few months ago… I had the opportunity to attend Day 2 of the USTDA workshop, the second of five regionally focused workshops in an effort to foster discussions on the most effective regulatory practices for medical devices, with the overarching goal of promoting harmonisation with international standards and achieving convergence in healthcare regulatory systems. What a time to be alive! It’s a time for interaction and learning between industry, stakeholders, including local and international regulatory authorities….A time for growth for the industries at large.

Join us for our third and final webinar in our series "Certifying medical devices in Europe". On the agenda: Understanding clinical evaluation requirements of MDR 2017/745.

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

21st August Webinar: Did you know that two identical products can face vastly different regulatory landscapes depending on their declared use? Take, for instance, a simple absorbent pad: whether it’s labelled as a baby diaper or an incontinence pad for adults can result in a regulatory journey that varies by years, requiring different studies and approval processes. And when you consider launching such a product in multiple countries, the complexity grows exponentially. This makes strategic planning essential when entering the medical device market. In this webinar, Anne Arndt, CEO and Regulatory Consultant at Johner Institute New Zealand, will demystify the intricate web of regulations that govern medical devices. Anne will offer practical advice on how to navigate these requirements effectively, helping you reduce approval times, minimise costs, and avoid unnecessary complications. Join us on the 21st of August for an invaluable session with one of the leading experts in the field. This is your chance to learn how a smart regulatory strategy can make all the difference in successfully bringing your product to market. Book NOW via https://lnkd.in/eSgZWUTb

Reminder regarding this webinar tomorrow!

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"?

Don't Miss Out! We will be speaking at the Regulatory 101 Workshop at DMD Conference (University of Minnesota's Design of Medical Devices Conference) Monday, April 8, 8:00am - 5:00pm CDT Continental Breakfast, Lunch, Coffee, Tea, and Snacks included. A brilliant design for a medical device is only the first step. To successfully bring your device to market, you must navigate the complex world of regulatory compliance. This full-day workshop, led by some of the most respected experts in the field, will provide you with the essential knowledge and tools to overcome the ever-increasing challenges of medical device regulations. Workshop Highlights: •Overview of medical device regulations and quality management systems •Navigating FDA submissions, including Pre-Submissions, 510(k), De Novo, and PMAs •Compliance essentials: advertising, promotion, and clinical investigations •Introduction to EU and international regulations •Best practices for risk management, post-market surveillance, and working with the FDA. Whether you're new to the medical device industry or a seasoned professional looking to refresh your knowledge, this workshop is a must-attend event. Featured Speakers: Lisa Pritchard, Vice President of Regulatory, Quality, Clinical and Engineering Aaron Hage, Senior Director of Legal-Regulatory & Compliance Kathy Herzog, Senior Regulatory, Quality & Compliance Consultant Secure your spot here: https://lnkd.in/gnERCWix

An excellent forum with abundant information to share! The world of Medical Devices is in a constant state of development and change

📌 In the final edition of Med Tech Monday for 2023, we look at the latest regulatory news from the FDA, plus why two senators are calling for a GAO review of the agency's oversight processes. From 2024, Med Tech Monday will become a monthly newsletter, so we can deliver more in-depth and focused news from the world of medical device regulations. Like, subscribe, and comment below. hashtag#regulation hashtag#FDA hashtag#medtech