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🌟 Exciting Speaker Announcement! 🌟 We are delighted to announce that Joel Ironstone will be speaking at our Medical Device Quality Assurance and Regulatory Affairs Conference on October 8-9 in Stockholm, Sweden! Joel Ironstone is a medical technology development expert with over 25 years of experience developing novel medical technologies. His experience includes technical development, regulatory approvals and the design and execution of first-in-human and pivotal clinical trials. He has brought more than a dozen innovative healthcare products from concept through to commercialization, and has held executive positions as CEO, COO, VP Product Development, and VP Clinical and Regulatory Affairs. Joel has been providing strategic regulatory and product development consulting support to medical device companies across many therapeutic areas and has led numerous successful FDA submissions for products of all classes. He is currently Vice President at Avania. In his session, "How to Cross the Atlantic: Adapting European Expertise for U.S. Regulatory Success," Joel will cover: ◾ Classification and Regulatory Pathways in the U.S. (and how they differ from Europe) ◾ Overview of the 510(k), De-Novo, and PMA processes ◾ More on the 510(k) Process—Demonstrating Substantial Equivalence ◾ When and how to talk to the FDA ◾ Other programs (Breakthrough Designation, SteP, HUD) ◾ Key differences in evidence required for U.S. vs. EU, including clinical evidence and biocompatibility This is a unique opportunity to gain valuable insights from a top expert in the field. 📅 Date: October 8-9, 2024 📍 Location: Stockholm, Sweden 🔗 Register now and visit our website for more details: https://lnkd.in/dbznGMcZ Don’t miss out on this chance to learn from one of the leading authorities in medical technology!

🌞 We’re back and ready to roll! After a refreshing summer break, the team at Key2Compliance is excited to dive back in and support our amazing customers. We offer comprehensive solutions in regulatory compliance, quality assurance, clinical development, and more — tailored specifically for Medical Device, IVD, and pharmaceutical companies. Whatever your needs, we’re here to help and make the second half of the year even more successful together! 🚀 Need our support? Reach out to us anytime through our website 🌐

📢 Discover the Speakers at the Medical Device Product Life Cycle Conference: October 8-9 in Stockholm! Don’t miss our international conference tailored to navigating the complexities of medical device regulations and standards. This is your chance to gain essential knowledge and insights from top industry leaders who will simplify complex processes and provide invaluable tools. Why Attend? Whether you're a Quality or Regulatory specialist, involved in design and development, clinical/performance evaluations, post-market clinical follow-up, process development, or Quality Assurance/Regulatory Affairs, this conference is essential for staying ahead in your field. What to Expect: Our agenda covers key activities from both the pre- and post-market phases and features: ◾ Expert insights from industry leaders ◾ Legal perspectives and patient experiences ◾ Input from multiple Notified Bodies Featured Speakers: ◾ Sharmila Gardner, Technical Documentation Manager & Head of UK Approved Body - Intertek Medical Notified Body ◾ Pontus Gedda, Medical Device Specialist - RISE Research Institutes of Sweden ◾ Anna Kuptel, Team Leader Site Auditor - TÜV SÜD ◾ Richard Holborow, Global Head Clinical Compliance - BSI ◾ Judith de Wilde, Attorney at Law – Axon Lawyers ◾ Sandra Larsson, Consultant & Life Science Industry Lead – TECHNIA ◾ Erik Hansson, Expert in Global Harmonisation of Medical Device Regulations ◾ Azadeh Hajipour, Senior Regulatory Consultant – Key2Compliance ◾ Henrik Eriksson, Dialysis Patient from Njurförbundet ◾ Dr. Madlon Timme & Dr. Kristina Then - GBA Group Pharma & Medical Devices ◾ Cyrille Michaud, Managing Partner from MD101 Consulting 🔍 Want to know what these experts will be presenting? Visit our website to read more about the speakers and their presentations at the conference. 🚀 Seats are filling up fast! Register now to secure your spot and stay ahead in the evolving world of medical device innovation. 💡👉🏻https://lnkd.in/dbznGMcZ #GBAGroup

🌟 Don’t Miss Out on Key2Compliance's Webinars! 🌟 At Key2Compliance, we're dedicated to helping medical device professionals stay ahead with the latest best practices in regulatory compliance. Our collection of FREE webinars—covering topics like change management, clinical evaluation, IVDR, CAPA, and more—is available for you to explore on our website. Whether you're still enjoying summer or have already returned to work, these webinars are a great way to catch up at your own pace and prepare for the upcoming fall season. 🔗👉🏻 https://lnkd.in/dTd9P-Vm Key2Compliance is more than just a service provider; we’re your full-service partner in regulatory compliance. If you want to learn more about how we can support your needs in the medical device, In Vitro Diagnostics, and pharmaceutical sectors, don’t hesitate to get in touch.

🔔 Exciting News! Announcing 3 more esteemed speakers for the Medical Device Product Life Cycle Conference 🔔 Join us on October 8-9 in Stockholm, Sweden for an international conference focused on mastering medical device regulations and standards. Our expert speakers will provide invaluable insights and tools to simplify the complexities of product safety and regulatory compliance. 📢 Dr. Madlon Timme, Senior Expert Biological Evaluation, and Dr. Kristina Then, Professional Customer Service from GBA Medical Device Services. Presentation: Medical Device Product Life Cycle from the Perspective of a Medical Device Testing Laboratory – Biocompatibility, Cleanliness, Single/Repeated Processing 📢 Cyrille Michaud, Managing Partner from MD101 Consulting Presentation: Working with AI-based products – How to Add ISO 42001 Compliance to Your ISO 13485 QMS 🚨 Don't miss out! Time is running out and seats are filling up fast. 🚨 This is a must-attend event for professionals in product safety, Quality Assurance, Regulatory Affairs, and more. Secure your spot today! https://lnkd.in/dbznGMcZ #medicaldevices #GBAGroup #GBAGroupPharmaMedicaldevices

Ensure Your Medical Device Classification is Spot On from the Start!🎯 Accurately determining the risk classification for your medical device or IVD product is crucial from the outset. It's one of the initial and most critical steps in bringing your product to market. Given the diversity of medical devices, we know how daunting classification can be. That’s why we're here to offer expert guidance!💡 Discover more about the significance of medical device classifications here: 👇🏻

⚡ Revisiting Our Popular Blog Post: IEC 60601 – Meeting the Electrical Safety Standards of Medical Devices ⚡ Our blog post on electrical safety in medical devices was a hit! Electrical devices are crucial in life sciences and medical technology, but they come with risks like electrical shock and fire hazards. Dive into the intricacies of meeting the rigorous standards of IEC 60601 with us once again. Explore this vital topic to bolster safety and reliability in your medical device design and development efforts. #MedicalDevices #ElectricalSafety #IEC60601 #MedicalTechnology

Classify your medical device with our AI-classifier! 🤖 Are you unsure about how to classify your medical device? Classification lays the foundation for your regulatory strategy and sets the framework for when and how to bring your idea to market. With Key2Compliance's AI-classifier, this process is made straightforward. Input the details of your medical device into our user-friendly form and receive the classification results in just seconds. ⏰ We believe that regulatory compliance should be a catalyst for innovation, not a roadblock! Our tool is easy to use and free of charge. And if post-classification guidance is required, our team is always prepared to support. 👉🏻Try our AI-classifier today! https://lnkd.in/ddjxt4ai #ai #medicaldevice

Have you ever been unsure whether the device you work with qualifies as a medical device? You're not alone. Medical devices span a vast range of technologies—there are approximately 2 million types worldwide, as per WHO. They vary in shape, size, functionality, and complexity. With rapid technological advancements, it's increasingly challenging for manufacturers to determine if their product falls under medical device regulations. In this blog, Olivia (Yi-Qin) Sun, Senior Consultant in Regulatory Affairs, offers a step-by-step guide to help you navigate the process of classifying your device in the EU. Don’t miss out on valuable insights to avoid common pitfalls!

🤖 Simplify medical device classification with Key2Compliance's AI-classifier! Unsure about classification? It's crucial for market strategy and now made easy. Just input your device details into our quick form and get results in seconds. Regulatory compliance should boost innovation, not hinder it. Our free tool is user-friendly, with expert guidance available post-classification. ⏰ Try our AI-Classifier today! 👉🏻https://lnkd.in/ddjxt4ai