Kennedys’ Post

📣 Exciting news for the MedTech industry! 🚀 Are you looking to launch a regulated product in the EU market but feeling overwhelmed by the new Medical Device Regulations (#MDR)? Or perhaps you have questions about the recently announced AI Act? Look no further! Our Head of Quality and Regulatory Consulting recently participated in a panel discussion alongside industry experts gMendel and Ente Certificazione Macchine srl, where they shared valuable insights on navigating the EU regulatory landscape. Whether you're a startup or an established player in the MedTech field, this discussion is a must-watch! It's filled with knowledge and experience that can help you stay compliant and successfully bring your healthcare solutions to the market. Don't miss out on this opportunity! Gain valuable insights and learn from industry leaders by checking out the panel discussion now. If you have any further questions or need assistance with launching your regulated products in the EU, feel free to contact us. We're here to help you navigate the complexities of the regulatory environment and ensure your success. Let's revolutionize the MedTech industry together! 🤝 #MedTech #ProductLaunch #HealthCareSolutions #MDR #AIAct #RegulatoryCompliance #EURegulations #Innovation #HealthTech #MedTechIndustry #PanelDiscussion #GlobalHealthcareSolutions #LinkInBio 🌐

For medtech manufacturers, the journey from concept to market is filled with regulatory hurdles. But what if compliance became a stepping stone for innovation? Are you leveraging regulatory compliance for market advantage? At TÜV SÜD, we're more than just compliance experts. We're your strategic partners in the medtech world. Read more in our recent blog post – “Navigating Regulatory Requirements And Market Access In Medical Device Manufacturing” with Adam True - https://lnkd.in/en2wFbxj #MedTech #HealthTech #Innovation

⚕️ Big news for #MedTech leaders: the FDA has finally drawn the line between servicing and remanufacturing medical devices! 🛠️💡 Understanding these regulations is crucial - it's no longer just a grey area of technicalities. Whether you're a CTO optimizing in-house equipment or a startup innovating in patient care, staying ahead of the compliance curve is key. 📈 For those who've been awaiting this clarity, it's time to delve into the details. And for my network of execs, especially in #HealthTech and #BioTech, let's ensure our operations and collaborations remain on the right side of regulations. 🧬🤝 🔍 Remember, it's not just about maintaining gear; it's about ensuring performance and safety at every turn. The FDA's new guidance can be your roadmap. 🗺️ Let's chat below or DM if you want to dive deeper into what this means for your company! 📩 #FDA #MedicalDevices #RegulatoryCompliance

Looking to launch a medical device in Europe. This is for you. We'll guide you on the way. Seeking clarity on the AI Act or #MDR? Our Head of Quality and Regulatory Consulting has you covered. Watch our panel discussion with gMendel and Ente Certificazione Macchine srl to gain essential knowledge on navigating #EUregulations for a successful product launch. ➡️ https://okt.to/QuWeyO #MedTech #HealthTech

Register today for the Governance, Innovation, And AI-Powered Solutions In The Global Regulation Of MedTech webinar presented by IQVIA on Thursday, March 21st, 2024. In the rapidly evolving landscape of MedTech, this webinar delves into the multifaceted realm of medical device technologies and the pivotal role of governance in shaping global regulations and standards. The complexity in the breadth of medical devices/technologies and the principles of governance in global regulation and standards. The regulatory, financial, and innovation drivers in the industry and how eQMS/end-to-end workflows support industry professionals in their market access activities. The possibilities with AI-powered solutions and the applications to quality, regulatory and safety solutions in the MedTech industry. Register now: https://ow.ly/An1k50QIUvZ #MedTechWebinar #GovernanceInnovation #GlobalRegulation

In the fluid sphere of MedTech development, regulatory compliance is not just a checkbox! It's a crucial assurance of safety, efficacy, and market access. Many in the industry agree Regulatory Compliance is thwart with issues, such as: Regulatory Compliance Hurdles One of the persistent challenges faced in our journey is the risk of non-compliance. The repercussions are far-reaching, encompassing legal entanglements and obstacles in market access. Whether it's improper labeling, inadequate testing protocols, or missing documentation, the consequences are undeniable. Fixable with a V&V framework We understand the stakes involved. Our approach to Verification and Validation is about exceeding standards. For the past 20 years, we've honed a robust framework that mitigates the risk of regulatory pitfalls and ensures a seamless pathway to compliance. Join the conversation! #MedicalDevices #RegulatoryCompliance #Validation #Innovation #Healthcare #MedTech #ProductDevelopment #RiskManagement #Regulation #MustRead #blog

In the fluid sphere of MedTech development, regulatory compliance is not just a checkbox! It's a crucial assurance of safety, efficacy, and market access. Many in the industry agree Regulatory Compliance is thwart with issues, such as: Regulatory Compliance Hurdles One of the persistent challenges faced in our journey is the risk of non-compliance. The repercussions are far-reaching, encompassing legal entanglements and obstacles in market access. Whether it's improper labeling, inadequate testing protocols, or missing documentation, the consequences are undeniable. Fixable with a V&V framework We understand the stakes involved. Our approach to Verification and Validation is about exceeding standards. For the past 20 years, we've honed a robust framework that mitigates the risk of regulatory pitfalls and ensures a seamless pathway to compliance. Join the conversation! #MedicalDevices #RegulatoryCompliance #Validation #Innovation #Healthcare #MedTech #ProductDevelopment #RiskManagement #Regulation #MustRead #blog

Learn how we work with global #medicaldevice companies to navigate the complexities of clinical investigations and regulatory pathways through our value-focussed #MedTech #Clinical & #Regulatory services. 👉 MedTech Regulatory Excellence: Navigate regulations seamlessly, ensuring your medical devices meet global standards such as #EUMDR / #IVDR. 🚀 Quality Focussed Clinical Investigations: We specialize in conducting clinical investigations across different classes of medical devices, accelerating high-quality scientific outcomes for regulatory approval. 🌍 Medical Device Market Access & Compliance: Techsol ensures your products comply with international requirements, facilitating market entry worldwide. Seeking a global partner to streamline your #MedTech regulatory process and accelerate market entry? Connect with Techsol Life Sciences today! 🌐💼 https://lnkd.in/eyHaA7Fr #MedTech #ClinicalRegulatory #TechsolLifeSciences #MedicalDevices #GlobalCompliance #MarketAccess #HealthcareInnovation

In the fluid sphere of MedTech development, regulatory compliance is not just a checkbox! It's a crucial assurance of safety, efficacy, and market access. Many in the industry agree Regulatory Compliance is thwart with issues, such as: Regulatory Compliance Hurdles One of the persistent challenges faced in our journey is the risk of non-compliance. The repercussions are far-reaching, encompassing legal entanglements and obstacles in market access. Whether it's improper labeling, inadequate testing protocols, or missing documentation, the consequences are undeniable. Fixable with a V&V framework We understand the stakes involved. Our approach to Verification and Validation is about exceeding standards. For the past 20 years, we've honed a robust framework that mitigates the risk of regulatory pitfalls and ensures a seamless pathway to compliance. Join the conversation! #MedicalDevices #RegulatoryCompliance #Validation #Innovation #Healthcare #MedTech #ProductDevelopment #RiskManagement #Regulation #MustRead #blog