Aligned AG

🥁 EXPERT'S SECRET #7 🥁 How can risks be controlled in SaMD? 👉 https://lnkd.in/dm6kMPbd 🚨Does this sound familiar: “Software constantly fails”? 🚨 When managing 𝐬𝐨𝐟𝐭𝐰𝐚𝐫𝐞 𝐫𝐢𝐬𝐤𝐬, this common refrain can be discouraging. But why should you invest in and maintain a robust software development process? The answer is simple: it leads to fewer bugs, happier patients, and reduced exposure to harm. 💡 Dive into expert advice from Christian Kaestner to discover why implementing risk control measures in SaMD makes a real difference. Let’s move away from the pessimistic view that failure is inevitable and explore strategies to take control of software risks. 𝐀𝐛𝐨𝐮𝐭 𝐨𝐮𝐫 𝐄𝐱𝐩𝐞𝐫𝐭, Christian Kaestner: Christian Kaestner is a consultant, entrepreneur, and Course Instructor at Medical Device HQ with extensive expertise in the medical device industry. As a key contributor to IEC 62304 and IEC 82304-1, he has vast experience in medical device development and software engineering. His roles have included software developer, project manager, auditor, and quality management professional. In our 𝐬𝐞𝐫𝐢𝐞𝐬 "𝐄𝐱𝐩𝐞𝐫𝐭’𝐬 𝐒𝐞𝐜𝐫𝐞𝐭” we address the pain points and pitfalls in the medical device design development process, seeking answers and solutions from leading industry experts. At Aligned AG, we're here to support your medical device design process every step of the way! 💯 #SaMD #MedicalDevices #SoftwareEngineering

🎉 Wrapping Up an Incredible 2024! 🎉 A heartfelt thank you to our amazing Aligned community and followers! 2024 has been an intense year, filled with exciting milestones and unforgettable moments. Here's a short overview of what we achieved together: ✅ Launched Aligned Elements V.3.0 – our latest software release! ✅ Hosted two successful webinars “Sharpen Your Skills” with fantastic med-tech industry leaders. ✅ Settled into our new Zurich office. ✅ Boosted our LinkedIn social media presence. ✅ Achieved ISO 27001 certification. ✅ Welcomed a new team member, Remo Steiner. And just yesterday, we celebrated all these milestones! 🏒 Played some hockey. 🍷 Warmed up with Glühwein at the Zurich Christmas Market. 🧀 Enjoyed a classic Swiss cheese fondue. 🎁 Had some fun “Wichteln” (secret gift exchange). This year has been all about keeping the momentum, and expanding our community. At Aligned AG, our mission is simple: help you develop innovative Medical Devices faster and with fewer resources. That’s why our ALM software 𝐀𝐥𝐢𝐠𝐧𝐞𝐝 𝐄𝐥𝐞𝐦𝐞𝐧𝐭𝐬 is the #1 choice for MedTech professionals. 👉https://lnkd.in/df6E2gAW 🎄 Wishing everyone a wonderful Christmas and a joyful holiday season. Here’s to an even brighter 2025! #TeamAligned #Milestones2024 #MedTechInnovation

🥇Discover how Modern Design Control Management can accelerate your Medical Device Development!🥇👉 https://lnkd.in/d4SFNUMA Streamline your Modular Design Documentation with 𝐀𝐥𝐢𝐠𝐧𝐞𝐝 𝐄𝐥𝐞𝐦𝐞𝐧𝐭𝐬: ⬇️ Cut Technical Documentation time by 30% ⬇️ Reduce Design Documentation effort by 80% ⬆️ Achieve savings of up to 80%! Let’s help you get your CE Mark faster! 𝐒𝐭𝐚𝐫𝐭 𝐲𝐨𝐮𝐫 𝐅𝐫𝐞𝐞 𝐓𝐫𝐢𝐚𝐥 𝐨𝐟 𝐀𝐥𝐢𝐠𝐧𝐞𝐝 𝐄𝐥𝐞𝐦𝐞𝐧𝐭𝐬 𝐭𝐨𝐝𝐚𝐲! 👉https://lnkd.in/df6E2gAW ❇️Happy Holidays!❇️ #MedicalDevices #Innovation #Documentation

🌟 Aligned Elements - A Vision for Medical Device Development Documentation 🌟 At Aligned AG, our mission is simple: help you develop innovative Medical Devices faster and with less resources. Our ALM system, 𝐀𝐥𝐢𝐠𝐧𝐞𝐝 𝐄𝐥𝐞𝐦𝐞𝐧𝐭𝐬, ensures compliant development documentation for regulated products in the Medical Device Industry. Ready to see why our software is the #1 choice for you? Start your free trial today: 👉 https://lnkd.in/df6E2gAW #MedicalDevices #Innovation #Regulatory #Compliance

🚨 New Tips & Tricks Alert 🚨 Are you a medical device software developer? If so, aligning your processes with IEC 62304 - Medical Device Software is critical! During audits, demonstrating compliance with this standard can be challenging! But we’ve got you covered.💡 Check out our 𝐈𝐄𝐂 𝟔𝟐𝟑𝟎𝟒 𝐂𝐡𝐞𝐜𝐤𝐥𝐢𝐬𝐭, fully integrated into 𝐀𝐥𝐢𝐠𝐧𝐞𝐝 𝐄𝐥𝐞𝐦𝐞𝐧𝐭𝐬. Aligned Elements Users can download and use our checklist 👉 https://lnkd.in/dDPTCGvt It includes 93 prepared audit questions based on IEC 62304 requirements, providing a fast and trackable way to prove compliance. ✅ Simplify your process ✅ Save time during audits ✅ Ensure compliance effortlessly 📩 Questions? Contact us at support@aligned.ch or start your 𝐟𝐫𝐞𝐞 𝐭𝐫𝐢𝐚𝐥 𝐨𝐟 𝐀𝐥𝐢𝐠𝐧𝐞𝐝 𝐄𝐥𝐞𝐦𝐞𝐧𝐭𝐬 today 👉 https://lnkd.in/df6E2gAW #MedicalDeviceSoftware #IEC62304 #Compliance

Aligned AG is now ISO 27001 Certified! 🏆 We are so proud to announce that Aligned AG has obtained its ISO 27001:2022 certification. We got the best team! 👉 https://lnkd.in/dEfpuZw6 A big thank you to all you “aligners” and friends for your dedication to ensuring we meet the highest standards in Cyber Security Management. 🔐 This ISO/IEC 27001:2022 certification a significant milestone emphasizing our commitment to information security and trust. 🔐🎉 Naturally, we used 𝐀𝐥𝐢𝐠𝐧𝐞𝐝 𝐄𝐥𝐞𝐦𝐞𝐧𝐭𝐬 to manage ISO 27001:2022 all documents and records. If you want to know more about how we did it, let us know.  #ISO27001 #Cybersecurity

🌟MedFIT Event 2024! Amazing visitors, exhibitors, and conversations all around.🌟 A heartfelt thank you to the organizers and everyone who stopped by! 🤝 For Aligned AG, this event was truly inspiring. To everyone who visited our booth: thank you! We hope we inspired and convinced you of Aligned’s expertise and why 𝐀𝐥𝐢𝐠𝐧𝐞𝐝 𝐄𝐥𝐞𝐦𝐞𝐧𝐭𝐬 is the #1 software solution for accelerating your medical device development process. 🚀 Let’s keep the momentum going - stay connected, and let’s shape the future of MedTech together! 💡 #medicaldevice #technicaldocumentation #SaaS

🌟 Are you a medical device professional? Are you looking for an ALM software? 🌟 Join us at MedFIT Event 2024 in Lille, France! 🚀 Swing by 𝐁𝐨𝐨𝐭𝐡 𝐍𝐨. 𝐅𝟑𝟑 to meet our passionate Aligned AG Team! This is a fantastic opportunity to connect, share insights, and exchange stories. Whether you're looking to streamline your regulatory processes or just want to learn more about our solutions, discover how Aligned can support you in creating Technical Files and Design Control Documentation with confidence. Learn more, why our software 𝐀𝐥𝐢𝐠𝐧𝐞𝐝 𝐄𝐥𝐞𝐦𝐞𝐧𝐭𝐬 is the number #1 choice for you! Find the Aligned AG Team at: 📍 Booth F33 🗓️ December 3 - 4, 2024 📌 Lille Grand Palais, Lille, France Vive l’innovation! Vive Aligned Elements! Visit us at MedFIT, Lille! #MedTechInnovation #MedicalDevices #MedFIT2024

📢 Countdown to MedFIT Event 2024! Only 1 More Day! We’re excited to meet Med Tech professionals and medical device development experts. Stop by to discover 𝐀𝐥𝐢𝐠𝐧𝐞𝐝 𝐄𝐥𝐞𝐦𝐞𝐧𝐭𝐬, our innovative Application Lifecycle Management (ALM) software designed specifically for medical device developers. Find the Aligned AG Team at: 📍 Booth F33 🗓️ December 3 - 4, 2024 📌 Lille Grand Palais, Lille, France Have questions or want to set up a meeting? Reach out at info@aligned.ch. We can’t wait to meet you! #MedTechInnovation #MedicalDevices #MedFIT2024