Essenvia

Our latest Webinar is now available on demand. Check out this session where we debunk the main myths about the implementation of RIM solutions in MedTech. Link to video: https://lnkd.in/dRDTgSCg

🚨 TODAY: Last call for our Webinar on "Adopting a RIM Platform in MedTech". We’ll debunk common myths about adopting Regulatory Information Management (RIM) technology in the MedTech industry, helping you make informed decisions about integrating RIM solutions. Registration link: https://lnkd.in/djsUwsni

There are still a few available seats—don’t miss out on this webinar on Sep. 26! We'll debunk common myths about adopting Regulatory Information Management (RIM) platforms in MedTech. Don’t let misconceptions hold you back from RIM adoption -> register now: https://lnkd.in/djsUwsni

Fantastic session by Soumya Mahapatra and Dhriti R. today at RAPS Convergence! They discussed the future of Regulatory Affairs in MedTech and shared insights on leveraging Regulatory Intelligence and data-driven solutions.

We´re thrilled to kick off RAPS Convergence 2024 in Long Beach! Looking forward to insightful discussions and exciting days 🚀

Join us for an eye-opening session where we'll uncover the truth about the adoption of Regulatory Information Management (RIM) platforms in MedTech. We´ll cover: 🔹 The truth behind the most common myths about implementing RIM platforms in medical device companies. 🔹 How RIM platforms can streamline your regulatory workflows, integrate with existing systems, and enhance compliance, all while quickly delivering results and significant return on investment. Many medical device companies are hesitating to adopt game-changing RIM platforms due to common misconceptions, which we’ll debunk during this webinar! Register Now: https://lnkd.in/dnWrvDMJ

Essenvia will be sponsoring RAPS Convergence 2024 in Long Beach! We're preparing an insightful speaking session that will delve into the latest trends in regulatory intelligence and data-driven strategies. We'll share practical insights and real-world case studies. Don't miss the opportunity to learn how new technologies can streamline your regulatory processes and drive innovation.   See you there?

TOMORROW! Last chance to register. Key topics will include: 🔹 Generative Artificial Intelligence (GenAI) 🔹 The EU’s MDR and IVDR regulations 🔹 The US FDA’s Quality Management System Regulation (QMSR) ...and much more. Register Now: https://lnkd.in/djgruwcm

💡ESSENVIA voiCEOver: NAYSAYERS ARE EVERYWHERE AND IF YOU’RE NOT CAREFUL THEY CAN PREVENT YOUR MEDICAL DEVICE COMPANY from spreading its wings. This latest Essenvia voiCEOver journal entry by Essenvia CEO Soumya Mahapatra busts myths about RIM platforms used to manage MedTech regulatory workflows, including: 👉 “It's a massive cost that requires heavy stakeholder involvement from multiple teams.” ❌ FALSE 👉 “It will disrupt my regulatory team and how it currently works and functions.” ❌ FALSE 👉 “It takes years to start realizing the benefits.” ❌ FALSE Check out more truths in Soumya’s voiCEOver below👇👇 #MedTech #MedicalDevices #RIM #Regulatory #RegulatoryManagement #Essenvia 💡Founded in 2018, Essenvia is a MedTech RIM platform that gives you the tools you need to manage regulatory workflows across the total product lifecycle, accelerate global market access, and generate exponential business value. Discover more about what Essenvia can do for your MedTech company at Essenvia.com.

💡ESSENVIA ESSENTIALS: TWO TOP OFFICIALS IN THE US FDA’s DIGITAL HEALTH CENTER SAY “COMPLEXITY AND RISKS” POSED BY ARTIFICIAL INTELLIGENCE (AI) SOFTWARE in healthcare could be managed with LCM, or Lifecycle Management. “Since the 1960s, LCM has been essential to delivering reliable software,” Digital Health Center of Excellence (DHCoE) Director Troy Tazbaz and Digital Health Specialist John Nicol argue in a July 25 blog post focused on “the potential of leveraging LCM to address the unique challenges of generative AI [GenAI] in healthcare.” “Modern Software Development Lifecycles (SDLCs) embody LCM principles, offering a structured framework for planning, designing, implementing, testing, integrating, deploying, maintaining, and eventually retiring software,” Tazbaz and Nicol wrote. The blog post, found at https://rb.gy/rn849p, further says the DHCoE is working to “map the phases of a traditional SDLC to the specifics of AI software development,” which the center is calling AI Lifecycle, or AILC. Eric Henry, senior quality and regulatory compliance advisor for the law firm King & Spalding’s FDA and life sciences practice, explained on LinkedIn at https://rb.gy/wjnzuh that “the essence” of the DHCoE blog post is to “map [an AILC] to existing [SDLC] models, with further mapping of each AI-specific activity within a traditional SDLC to [international] standards and tools that may be used to execute and/or evaluate that outcome of that activity.” He went on: “I have to wonder if/how the agency will correlate the activities in its upcoming draft AI lifecycle guidance to the consensus medical device standards ubiquitous across the industry. I’m hopeful but now more uncertain.” The guidance Henry spoke of is a draft document the FDA plans to release in fiscal year 2024, which ends on Sept. 30. The agency says the draft will be titled “Artificial Intelligence/Machine Learning (AI/ML)-enabled Device Software Functions: Lifecycle Management Considerations and Premarket Submission Recommendations.” 👉👉Get more insights from Henry – this time about updating quality systems procedures in advance of the FDA’s upcoming Quality Management System Regulation (QMSR) implementation – in a two-part story found on Essenvia’s Media Hub at https://lnkd.in/dqWF2pi9. 💡Essenvia Essentials: Bite-Sized MedTech News for RA Professionals💡 Founded in 2018, Essenvia is a MedTech RIM platform that gives you the tools you need to manage regulatory workflows across the total product lifecycle, accelerate global market access, and generate exponential business value. Discover more about what Essenvia can do for your MedTech company at Essenvia.com. #AI #ArtificialIntelligence #FDA #DHCoE #Regulation #Regulatory #MedTech #MedicalDevices #Essenvia #RIM #RegulatoryManagement