Fasken’s Post

Join Sidley Austin LLP, ISS AG, Integrated Scientific Services AG, and Swiss Medtech for a webinar with insights from behind the scenes and practical tips on current issues regarding the Swiss regulatory landscape in the making. • Advantages and shortcomings of the EU #MDR and its impact on patient safety • Patients’ needs • Practical differences in the #regulation between Switzerland and the EU • Reliance on U.S. – A way out? • Recognition of #FDA-authorized #medicaldevices by Switzerland – Compatibility with the Mutual Recognition Agreement Switzerland/European Union 👉 Industry speakers, including our Co-CEO Bernhard Bichsel, scientific experts, and counsel will share tips and best practices for the challenges and opportunities that lie ahead for Swiss #MedTech enterprises. Target Audience: Executives, corporate lawyers, and regulatory professionals interested in or dealing with regulatory issues in Switzerland. This webinar is free of charge for members of Swiss Medtech and ASD as well as for all participants from the event in Bern on November 6, 2023. Program and Registration: https://lnkd.in/euWq5NDj #ISS #Medtech #MedicalDevice #MDR #FDA

Argentina's rise as a medtech clinical trial destination is driven by its adherence to quality standards, innovative medical device contributions, and strong healthcare infrastructure. The country's regulatory framework and growing market demand position it as a favorable location for global research. With a focus on efficiency and patient safety, Argentina offers a promising landscape for advancing medical science through clinical trials.

This initiative signals an important step towards a new regulatory framework for medical devices in Great Britain which protects public health, ensures access to MedTech innovations, and maintains an attractive market for industry - https://lnkd.in/eqhsb7ed

Clinical trials are the backbone of medical progress, yet Europe's system faces hurdles that can slow down innovation. A recent article by Sifted https://lnkd.in/ehJ3y9Ex explores these challenges and proposes solutions for a more efficient future. The article highlights the need for streamlined regulations, improved collaboration across borders, and leveraging technology to expedite the clinical trial process. By overcoming these obstacles, Europe can ensure faster access to life-saving treatments for patients. Head over to the full Sifted article to delve deeper into the current state of clinical trials in Europe and the exciting possibilities for an optimized system. #Planimeter #ClinicalTrials #Europe #BlogRecap

🚀 Episode 10 of the MedTech Matters Video series is now live! Join us as Dr. Kenneth Ouriel, Chief Medical Officer at NAMSA, delves into the crucial Strategies for Selecting the Proper Investigational Sites for Pivotal Studies. 🏥 Discover expert insights on optimizing your clinical trials for success. Don't miss out on this invaluable resource for medical device professionals! 🎥 Watch now and elevate your study strategy: https://lnkd.in/gj7-au2q #MedTechMatters #ClinicalTrials #MedicalDevices #NAMSAKnows #PivotalStudies

Curious about the common pitfalls in the clinical trial site selection process? Spend a few minutes watching the below video as NAMSA's Chief Medical Officer Dr. Ken Ouriel shares helpful insights to overcome these challenges as well considerations for partnering with MedTech focused CRO’s to help navigate this potentially time consuming aspect to bringing lifesaving technologies to market. Please reach out if you're looking for a MedTech focused CRO for your next clinical trial.

MedTech Europe congratulates President Ursula Von der Leyen on her re-election as President of the European Commission and is eager to support her vision for enhancing European competitiveness and business efficiency. The medical technology sector is committed to collaborating with the European Commission and EU co-legislators to maintain Europe's leadership in innovative medical technology and efficient healthcare systems. Emphasising the need for patient-centric, resilient, and digitally advanced healthcare, MedTech Europe calls for policies that ensure equitable access to top-tier healthcare, foster a unified digital health ecosystem, and build financially and environmentally sustainable healthcare systems.

NAMSA has so many industry experts who can absolutely guide you and your team through the strategies for selecting the proper investigational sites and so much more. #MedTechMatters #ClinicalTrials #MedicalDevices

Exciting news from the healthcare sector! Medicare Services has announced a significant development in coverage for breakthrough devices. With the introduction of the Transitional Coverage for Emerging Technologies pathway, CMS will now evaluate five medical device candidates annually for national coverage. We look forward to more updates on the latest advancements in healthcare technology! 💡 #Medicare #Healthcare #Technology #CMS #MedicalDevices