Aligned Elements offers Medical Device Application Lifecycle Management (ALM) software for managing Design History Files, focusing on aspects like requirements management, risk management, and regulatory compliance.

Aligned Elements

Aligned AG | 1,113 followers on LinkedIn. We provide Aligned Elements, an ALM system to ensure compliant documentation for the Medical Device Industry. | Aligned (www.aligned.ch) provides Aligned Elements, an Application Lifecycle Management (ALM) software for Medical Device development.

We assist our clients in developing, manufacture and market regulatory compliant products within shorter timeframes, to lower costs and with higher confidence. 

At Aligned, we believe that management of product and project documentation of regulatory compliant products shall be efficient and pragmatic.

Director of Sales at Aligned AG

Robert Riccetti

Dipl.Ing Systemtechnik FH, MAS in Software Engineering

Allan Brignoli

Aligned AG

💡 Did you know? Up to 50% of the total development effort for medical devices goes into documentation ❗ Let’s be honest: as medical device developers, we’d all rather spend time on innovation than on documentation. But here’s the advantage - companies that excel in technical documentation gain a powerful edge over their competitors by: ✅ Shifting resources to focus on innovation and build better products ✅ Achieving faster market access ✅ Accelerating revenue generation There’s untapped potential here! We’ll show you how to uncover it. Check out our video 👉 https://lnkd.in/ddud_txG to learn how medical device manufacturers can reduce documentation workload while staying compliant with regulations. If you want to assess your own documentation process, reach out to Aligned AG on info@aligned.ch #MedicalDevices #Innovation #RegulatoryCompliance

🚨 Final Reminder! 🌟 Curious what you missed at our "Sharpen Your Skills 2024" virtual seminar on October 22nd? 🌟 Catch up on all the insights, tips, and expert discussions whenever it suits you! For those who couldn’t join us live, 🎥 watch the 𝐟𝐮𝐥𝐥 𝐫𝐞𝐜𝐨𝐫𝐝𝐢𝐧𝐠 𝐨𝐟 𝐒𝐡𝐚𝐫𝐩𝐞𝐧 𝐘𝐨𝐮𝐫 𝐒𝐤𝐢𝐥𝐥𝐬 𝟐𝟎𝟐𝟒 here 👉 https://lnkd.in/dBjPjyB4 Here’s a quick look at what you missed: 🎤 @Dr. Anca-Sarmiza Gueltekin-Tigan , Senior Consultant, QUAREGIA GmbH - Quality & Regulatory Compliance (32 min) 🗣️ Topic: Decoding IVDR – Simplifying Software Classification for In Vitro Diagnostics 🎤 Thomas Bohnen , CEO, KEYMKR GmbH (34 min) 🗣️ Topic: Verification & Validation Plans – The Most Boring or the Most Important Document? 🎤 Dr. Ivo Locher , Program Manager, konplan AG (50 min) 🗣️ Topic: Product Requirements – How to Keep Them Manageable and Maintainable 🎤 Karl Johan Larsson Larsson, Technical File Specialist & Co-founder, Aligned AG (43 min) 🗣️ Topic: Hazard Analysis vs. FMEA vs. Cybersecurity Risks – Understanding Similarities and Differences ✨ Enhance your expertise and stay updated with the latest trends and best practices in Medical Device Development. ✨ 🚀 Stay connected, stay informed, and keep the momentum going! 🚀 We look forward to seeing you at our 𝐧𝐞𝐱𝐭 "𝐒𝐡𝐚𝐫𝐩𝐞𝐧 𝐘𝐨𝐮𝐫 𝐒𝐤𝐢𝐥𝐥𝐬" 𝐬𝐞𝐦𝐢𝐧𝐚𝐫 𝐢𝐧 𝐒𝐩𝐫𝐢𝐧𝐠 𝟐𝟎𝟐𝟓! #SharpenYourSkills #MedicalDeviceDevelopment #SaaS #MedTech #Webinar

🌟 EXPERT'S SECRET #5 🌟 How do you find the applicable standards and ensure compliance? Is there a master plan to follow? 👉 https://lnkd.in/dpByNhtd Discover 𝐛𝐞𝐬𝐭 𝐩𝐫𝐚𝐜𝐭𝐢𝐜𝐞𝐬 𝐢𝐧 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞 𝐝𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭 from industry expert Beat Keller , Founder & CEO of SMDC Swiss Medical Device Consulting GmbH , to help you better structure your development and documentation efforts! ❇️ About our expert, Beat Keller : Beat Keller is an electronics engineer specializing in Regulatory Affairs and Quality Management. He is the founder and CEO of SMDC Swiss Medical Device Consulting GmbH . Read more at 👉 https://www.smdc.ch/ 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! 💯 #MedicalDeviceDevelopment #compliance #ALMSoftware

🔔 Missed our "Sharpen Your Skills 2024" virtual seminar on October 22nd? Don't worry - we've got you covered! 🔔 For those unable to join live, the 𝐟𝐮𝐥𝐥 𝐫𝐞𝐜𝐨𝐫𝐝𝐢𝐧𝐠 𝐨𝐟 𝐨𝐮𝐫 𝐒𝐡𝐚𝐫𝐩𝐞𝐧 𝐘𝐨𝐮𝐫 𝐒𝐤𝐢𝐥𝐥𝐬 𝟐𝟎𝟐𝟒 𝐰𝐞𝐛𝐢𝐧𝐚𝐫 is now available! 🎥 Watch it at your convenience here 👉 https://lnkd.in/dBjPjyB4 A big thank you to our four outstanding speakers who shared invaluable insights: 🎤 Dr. Anca-Sarmiza Gueltekin-Tigan Gültekin-Tigan, Senior Consultant, QUAREGIA GmbH - Quality & Regulatory Compliance GmbH (32 min) 🗣️ Topic: Decoding IVDR – Simplifying Software Classification for In Vitro Diagnostics 🎤 Thomas Bohnen , CEO, KEYMKR GmbH (34 min) 🗣️ Topic: Verification & Validation Plans – The Most Boring or the Most Important Document? 🎤 Dr. Ivo Locher , Program Manager, konplan AG (50 min) 🗣️ Topic: Product Requirements – How to Keep Them Manageable and Maintainable 🎤 Karl Johan Larsson, Technical File Specialist & Co-founder, Aligned AG (43 min) 🗣️ Topic: Hazard Analysis vs. FMEA vs. Cybersecurity Risks – Understanding Similarities and Differences ✨ Boost your expertise and stay up-to-date with the latest trends and best practices in Medical Device Development. ✨ 🚀 Stay connected, stay informed, and keep the momentum going! 🚀 We look forward to seeing you at our next Sharpen Your Skills seminar in Spring 2025! #SharpenYourSkills #MedicalDeviceDevelopment #SaaS #MedTech #Webinar

🔔 Missed our "Sharpen Your Skills 2024" virtual seminar on October 22?🔔 No worries! The 𝐟𝐮𝐥𝐥 𝐫𝐞𝐜𝐨𝐫𝐝𝐞𝐝 𝐬𝐞𝐬𝐬𝐢𝐨𝐧 𝐢𝐬 𝐧𝐨𝐰 𝐚𝐯𝐚𝐢𝐥𝐚𝐛𝐥𝐞 for you to watch at your convenience. 🎥 Check out the webinar recording 👉 https://lnkd.in/dBjPjyB4 Gain valuable insights and stay ahead in the medical device development industry with presentations from our 4 expert speakers: 🎤 Dr. Anca-Sarmiza Gueltekin-Tigan , Senior Consultant, QUAREGIA GmbH - Quality & Regulatory Compliance (32 min) 🗣️ Topic: Decoding IVDR - Simplifying Software Classification for In Vitro Diagnostics 🎤 Thomas Bohnen , CEO KEYMKR GmbH (34 min) 🗣️ Topic: Verification & Validation Plan - The Most Boring or the Most Important Document? 🎤 Dr. Ivo Locher , Program Manager, konplan AG (50 min) 🗣️ Topic: Product Requirements - How to Keep Them Manageable and Maintainable 🎤 Karl Johan Larsson, Technical File Specialist & Co-founder, Aligned AG (43 min) 🗣️ Topic: Hazard Analysis vs. FMEA vs. Cybersecurity Risks - Understanding Similarities and Differences Elevate your expertise with the latest trends and best practices in Medical Device Development! ✨ We look forward to seeing you at 𝐨𝐮𝐫 𝐧𝐞𝐱𝐭 𝐒𝐡𝐚𝐫𝐩𝐞𝐧 𝐘𝐨𝐮𝐫 𝐒𝐤𝐢𝐥𝐥𝐬 𝐒𝐞𝐦𝐢𝐧𝐚𝐫 𝐢𝐧 𝐒𝐩𝐫𝐢𝐧𝐠 𝟐𝟎𝟐𝟓! Stay connected, stay informed, and keep the momentum going! 🚀 #SharpenYourSkills #MedicalDeviceDevelopment #MedTech #Webinar #SaaS

💪 Sharpen Your Skills 2024 delivered once again! 💪 A heartfelt thank you to our four amazing speakers: ❇️ Dr. Anca-Sarmiza Gueltekin-Tigan , Senior Consultant at QUAREGIA GmbH - Quality & Regulatory Compliance ❇️ Thomas Bohnen , CEO of KEYMKR GmbH ❇️Dr. Ivo Locher , Program Manager at konplan AG ❇️Karl Johan Larsson, Managing Director of Aligned AG And, of course, a big thank you to our fantastic audience! 🤝 With over 70 registrants, we had the pleasure of hearing 𝐭𝐨𝐩 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞 𝐞𝐱𝐩𝐞𝐫𝐭𝐬 share invaluable insights on overcoming common challenges in 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞 𝐝𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭. Missed this inspiring online seminar, live-streamed from Aligned AG headquarters? No worries! ⏰ We'll be sharing the recorded version in the coming days. Stay tuned! #SharpenYourSkills #MedicalDeviceDevelopment #SaaS

📢 Last call for "𝐒𝐡𝐚𝐫𝐩𝐞𝐧 𝐲𝐨𝐮𝐫 𝐒𝐤𝐢𝐥𝐥𝐬 𝟐𝟎𝟐𝟒"! Over 60 Med Tech Professionals have already registered for this 𝐞𝐱𝐜𝐥𝐮𝐬𝐢𝐯𝐞 𝐨𝐧𝐥𝐢𝐧𝐞 𝐬𝐞𝐦𝐢𝐧𝐚𝐫. Boost your expertise 𝐢𝐧 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭 and stay ahead of the curve! 📝 Register Now 👉 https://lnkd.in/gVQC2eFb ✨ Four top experts will lead the session, sharing their insights into key areas of medical device development: 🎤 Dr. Anca-Sarmiza Gueltekin-Tigan , Senior Consultant QUAREGIA GmbH - Quality & Regulatory Compliance 🗣️ 𝐓𝐨𝐩𝐢𝐜: Decoding IVDR: Simplifying Software Classification for In Vitro Diagnostics 🎤 Thomas Bohnen , CEO KEYMKR GmbH 🗣️ 𝐓𝐨𝐩𝐢𝐜: Verification & Validation Plan – The Most Boring or the Most Important Document? 🎤 Dr. Ivo Locher , Program Manager konplan AG 🗣️ 𝐓𝐨𝐩𝐢𝐜: Product Requirements – How to Keep Them Manageable and Maintainable 🎤 Karl Johan Larsson, Managing Director Aligned AG 🗣️ 𝐓𝐨𝐩𝐢𝐜: Design Risks vs FMEA vs Cyber Security Risks – Examining Similarities and Differences 𝐄𝐯𝐞𝐧𝐭 𝐃𝐞𝐭𝐚𝐢𝐥𝐬: 🗓️ Date: Tuesday, October 22nd, 2024 🕰️ Time: 13:30 - 16:30 CET 📍 Location: Live-streamed from Aligned AG HQ 📝 Register: Secure your spot by signing up via the LinkedIn event page. 👉 https://lnkd.in/gVQC2eFb 🔗 Teams Link: Available on the LinkedIn Event Page 🎙️ Presentations: Held in English 💡 Don’t miss this opportunity! Mark your calendars and join us! #MedicalDevices #SharpenYourSkills2024 #IVDR #Compliance #MedTech

Aligned AG is hosting Online Medical Device Development Seminar - Sharpen your Skills 2024 Part 2. Make sure to attend it tomorrow.

📢 Reminder: Don’t miss the upcoming "Sharpen Your Skills 2024" webinar!✨ As a Med Tech professional, this is an unparalleled opportunity you can't afford to miss! 📝 𝐑𝐞𝐠𝐢𝐬𝐭𝐞𝐫 𝐯𝐢𝐚 𝐭𝐡𝐞 𝐋𝐢𝐧𝐤𝐞𝐝𝐈𝐧 𝐞𝐯𝐞𝐧𝐭 𝐩𝐚𝐠𝐞: 👉 https://lnkd.in/gVQC2eFb Reserve your seat and join us on 𝐎𝐜𝐭𝐨𝐛𝐞𝐫 𝟐𝟐𝐧𝐝, 2024 for an enlightening afternoon focused on advancing your expertise in medical device development. Elevate your approach and stay ahead of industry challenges with insights from four brilliant speakers: 🎤 Dr. Anca-Sarmiza Gueltekin-Tigan Gültekin-Tigan, Senior Consultant QUAREGIA GmbH - Quality & Regulatory Compliance 🗣️ Topic: Decoding IVDR: Simplifying Software Classification for In Vitro Diagnostics 🎤 Thomas Bohnen , CEO KEYMKR GmbH 🗣️ Topic: Verification & Validation Plan – The Most Boring or the Most Important Document? 🎤 Dr. Ivo Locher , Program Manager konplan AG 🗣️ Topic: Product Requirements – How to Keep Them Manageable and Maintainable 🎤 Karl Johan Larsson, Managing Director Aligned AG 🗣️ Topic: Design Risks vs FMEA vs Cyber Security Risks – Examining Similarities and Differences 𝐄𝐯𝐞𝐧𝐭 𝐃𝐞𝐭𝐚𝐢𝐥𝐬: 🗓️ Date: Tuesday, October 22nd, 2024 🕰️ Time: 13:30 - 16:30 CET 📍 Location: Live-streamed from Aligned AG HQ 📝 Register: Secure your spot by signing up via the LinkedIn event page. 👉 https://lnkd.in/gVQC2eFb 🔗 Teams Link: Available on the LinkedIn Event Page 🎙️ Presentations: Held in English 💡 Don’t miss this chance and mark your calendars! Gain valuable insights and network with industry experts. See you there! #MedicalDevices #SharpenyourSkills #IVDR #Compliance

Aligned Elements provides Medical Device Application Lifecycle Management (ALM) software for managing Design History Files.

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