Sara Ramió Pujol’s Post

Key discussions today at the Swiss Medtech National Regulatory Conference 2024 in Bern! We’re tackling how European regulations are impacting innovation and the shift towards a trust-based system. Regulatory bodies need to work more closely with manufacturers, who are the real experts on their products, to streamline the process without compromising safety and trust. This isn’t just about regulators, it’s about the patients, too. We need to ensure that patients trust that the innovations reaching the market are safe, effective, and developed with their needs in mind. As Daniel Delfosse and Phil Brown pointed out, these challenges are shared across Europe, making collaboration between manufacturers, regulators, and patients essential for moving forward. #MedTech #Compliance #Regulatory #FDA #Healthcare

🌸 𝐖𝐡𝐞𝐫𝐞'𝐬 𝐭𝐡𝐞 𝐒𝐩𝐫𝐢𝐧𝐠 𝐁𝐮𝐳𝐳 𝐢𝐧 𝐌𝐞𝐝𝐭𝐞𝐜𝐡? 🌸 We are excited to announce the publication of a new edition of "𝐁𝐨𝐥𝐥𝐞𝐢𝐧𝐢𝐧𝐠𝐞𝐫'𝐬 𝐁𝐞𝐟𝐮𝐧𝐝" by DeviceMed.   In his latest commentary, Stefan Bolleininger explores the current state of regulatory affairs in the medtech industry. Highlights include updates on postponed IVDR deadlines, insights from the latest regulatory events, and the practical application of new guidelines. As the industry navigates these changes, staying informed is key to compliance and innovation.   For the complete article, follow this link: https://lnkd.in/debeQV35 #MedTech #RegulatoryAffairs #IVDR #HealthcareInnovation #DeviceMed

Stay informed and navigate the ever-evolving regulatory landscape with Market Pathways, your trusted source for comprehensive insights into global medtech regulations, reimbursement trends, and policy developments. Whether you're looking to stay ahead of critical changes or gain in-depth analysis on industry-shaping issues, Market Pathways offers the expertise you need. Visit our website or scan the QR code to explore how Market Pathways can support your strategic decisions in the medtech space. #medtech #regulatoryaffairs #medicaldevices #reimbursement #marketaccess #policyinsights

⏳13 mins to understand how Europe’s regulatory system for medical technologies could be improved to better serve patients’ needs +? 🎧Listen to #MedTechONAIR: bit.ly/MTOAS4E3    In this episode, we discuss with our Director of Regulatory Affairs, Petra Zollner, MedTech Europe’s Vision on how to tackle existing challenges in Europe’s regulatory systems and our recommendations on how to move our #healthcare systems forward.  

Recently, my collegue Sara Ramió Pujol and myself, hosted #AliraHealth latest webinar on navigating the complex #Regulatory landscape for #Medtech in both the EU and the US. During the session, we asked the audience: "On average, how long is it taking you to register a product?" ➡ The most frequent response was: 2-5 years. On October 30th, the European Commission released the latest findings from the #NotifiedBodies Survey, which aligns with the results we saw in our poll and exemplifies the challenges discussed during the webinar to achieve MDR/IVDR certification. Notably, the survey also revealed a high rate of certification refusals, highlighting the ongoing hurdles faced by the Medtech industry (https://shorturl.at/EVsiH) ➡If you missed our webinar, you can watch it now to help guide your regulatory strategy: https://lnkd.in/g3KD3BRX At #AliraHealth, we’re here to support you in tackling these regulatory challenges, from defining your strategy, building the technical documentation to implemening your QMS. #Regulatory #Medtech #MedicalDevices #NB #NotifiedBodies #MDR #IVDR

Last week, my colleagues, Sara Ramió Pujol and Irati Mendia Azkoaga, hosted #AliraHealth latest webinar on navigating the complex #Regulatory landscape for #Medtech in both the EU and the US. During the session, we asked the audience: "On average, how long is it taking you to register a product?" ➡ The most frequent response was: 2-5 years. On October 30th, the European Commission released the latest findings from the #NotifiedBodies Survey, which aligns with the results we saw in our poll and exemplifies the challenges discussed during the webinar to achieve MDR/IVDR certification. Notably, the survey also revealed a high rate of certification refusals, highlighting the ongoing hurdles faced by the Medtech industry (https://shorturl.at/EVsiH) ➡If you missed our webinar, you can watch it now to help guide your regulatory strategy: https://lnkd.in/g3KD3BRX At #AliraHealth, we’re here to support you in tackling these regulatory challenges, from defining your strategy, building the technical documentation to implemening your QMS. #Regulatory #Medtech #MedicalDevices #NB #NotifiedBodies #MDR #IVDR

📣 Attention #MedTech executives Please be sure to find me during the MedTech Strategist summit to learn how implementing the right #regulatoryaffairs strategy supports getting your innovative product from the bench to the patient more efficiently whilst meeting legislative requirements. A good regulatory affairs strategy saves time and resource to bring in revenue faster! Looking forward to our chat. Still time to register here: https://lnkd.in/ekEHJUNn #innovation #mdr #ivd #medicaldevice #diagnostic #regulatorycompliance #innovationdublin24

Medical device regulation in Europe Absolutely worth listening to. Petra Zollner illustrates the current situation of the European regulations MDR and IVDR and the need to revise them quickly (considering European peculiarities). With the current regulatory system (MDR/IVDR), medical devices really CANNOT BE USED in the best possible way for the BENEFIT of affected PATIENTS. And they are largely denied access to state-of-the-art devices. CONCLUSION: Switzerland, which is not part of the EU, is well advised to IMPLEMENT Motion 20.3211 IMMEDIATELY in order to ensure a good and up-to-date supply of devices. #fda #mdr #medicaldevices #cemark #confinis #medtech #ivdr #ivdv #mepv

⏳13 mins to understand how Europe’s regulatory system for medical technologies could be improved to better serve patients’ needs +?  🎧Listen to #MedTechONAIR: bit.ly/MTOAS4E3    In this episode, we discuss with our Director of Regulatory Affairs, Petra Zollner, MedTech Europe’s Vision on how to tackle existing challenges in Europe’s regulatory systems and our recommendations on how to move our #healthcare systems forward.  

FDA inspections are nobody’s idea of a good time. However, proper planning can go a long way to not only ensuring baseline compliance, but also to establishing an effective corporate culture and building long-term company value. In this edition of Consultants Corner, we spotlight advice from Jamie Harris, MPH, RAC and Nancy Lince, RAC, who discussed the issue onstage last month at the MedTech Strategist Innovation Summit in Dublin: https://bit.ly/44EOS1y #medicaldevices #medtech #fda #InnovationDublin24