Aligned AG

There is a systematic way for QA/RA teams to keep technical documentation MDR/FDA-compliant... ...without chasing R&D for missing evidence before every audit. Whether you're preparing for a Notified Body audit or maintaining several product lines under MDR, the problem is rarely your team. It's documentation spread across disconnected tools. In this guide you will learn: ✅ Why fragmented documentation systems silently create regulatory risk ✅ How Quality and R&D work from one traceable source instead of parallel files ✅ The 4-phase ALM implementation approach used by Biotronik and Tecan 📘 Download the guide now

How many hours did your R&D team spend on documentation last week – instead of engineering? When the trace matrix lives in Excel and someone keeps it alive by hand, every design change can silently break your Technical File. The MedTech Regulatory Readiness Playbook shows: ✅ The real cost of staying with a manual approach ✅ Why design controls – not documents – should be your single source of truth ✅ Where to start, based on where your team stands today 📘 Get the free playbook

MDR and FDA compliance shouldn't start the week before the audit. You passed your last audit. But could you honestly promise to pass an unannounced one next week? The MedTech Regulatory Readiness Playbook shows how Quality, Regulatory and Engineering leaders turn fragmented Technical Files into continuous readiness: ✅ Why fragmented Technical Files silently create regulatory risk ✅ The 5 levers of a continuous readiness system ✅ A self-test to see where your team stands 📘 Download the free playbook

MDR/FDA compliance is rarely lost in the audit. It's lost months earlier... ...in disconnected Word files, Excel trace matrices and email threads. That's why leading MedTech companies don't "prepare" for audits. They build compliance into development from day one. In this guide you will learn: ✅ Why fragmented documentation systems silently create regulatory risk ✅ The 4-phase ALM implementation approach used by Biotronik and Tecan ✅ How to keep requirements, risks and tests traceable through every design change 📘 Download the guide now

There is a systematic way for medical device teams to stay audit-ready every day... ...without a sprint before each audit or chasing evidence across spreadsheets. Whether you face a Notified Body audit or run several product lines under MDR, the problem isn't discipline. It's documentation in disconnected places. In this guide you will learn: ✅ Why fragmented tools quietly create audit risk ✅ How leading teams make compliance documentation a byproduct of development ✅ The single-source approach Biotronik uses to keep design, test, and risk documentation connected 📘 Get the practical guide

🤖 AI is changing medical device development. Are you ready? Our 𝗦𝗛𝗔𝗥𝗣𝗘𝗡 𝗬𝗢𝗨𝗥 𝗦𝗞𝗜𝗟𝗟𝗦 𝟮𝟬𝟮𝟲 webinar takes place next Tuesday - with a strong 𝗔𝗜 𝗳𝗼𝗰𝘂𝘀 𝗮𝗰𝗿𝗼𝘀𝘀 𝘁𝗵𝗲 𝗽𝗿𝗼𝗴𝗿𝗮𝗺𝗺𝗲. 👉 Link to registration: https://lnkd.in/eGsrynQy 𝗪𝗛𝗔𝗧'𝗦 𝗢𝗡 𝗧𝗛𝗘 𝗔𝗚𝗘𝗡𝗗𝗔? ❇️ 𝗧𝗼𝗽𝗶𝗰 𝟭: 𝗦𝗼𝗺𝗲𝗼𝗻𝗲 (𝗔𝗜) 𝘄𝗿𝗼𝘁𝗲 𝗺𝘆 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗘𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻. 𝗡𝗼𝘄 𝘄𝗵𝗮𝘁? 15:00 - 15:30 CET | by Florian Tolkmitt, Managing Director, PRO-LIANCE GLOBAL SOLUTIONS GmbH ❇️𝗧𝗼𝗽𝗶𝗰 𝟮: 𝗪𝗵𝗲𝗻 𝗔𝗜 𝗠𝗲𝗲𝘁𝘀 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗔𝗳𝗳𝗮𝗶𝗿𝘀: 𝗪𝗵𝗼 𝗜𝘀 𝗔𝗰𝗰𝗼𝘂𝗻𝘁𝗮𝗯𝗹𝗲? 15:30 - 16:00 CET | by Fabienne Speciale-Di Gennaro, Co-founder, RegAffinity GmbH - Konfira ❇️𝗧𝗼𝗽𝗶𝗰 𝟯: 𝗪𝗶𝗹𝗹 𝗔𝗜 𝘀𝗼𝗹𝘃𝗲 𝗮𝗹𝗹 𝗺𝘆 𝘁𝗲𝗰𝗵-𝗱𝗼𝗰 𝗽𝗿𝗼𝗯𝗹𝗲𝗺𝘀? 16:00 - 16:30 CET | by Anders Emmerich, CEO, Aligned AG ❇️𝗧𝗼𝗽𝗶𝗰 𝟰: 𝟲 𝗠𝗗𝗥 𝗧𝗲𝗰𝗵𝗻𝗶𝗰𝗮𝗹 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 𝗣𝗶𝘁𝗳𝗮𝗹𝗹𝘀 𝗳𝗿𝗼𝗺 𝗮 𝗡𝗼𝘁𝗶𝗳𝗶𝗲𝗱 𝗕𝗼𝗱𝘆'𝘀 𝗣𝗲𝗿𝘀𝗽𝗲𝗰𝘁𝗶𝘃𝗲 16:30 - 17:00 CET | by Alessio Quaranta, Medical Device Product Development Leader, Bureau Veritas Switzerland AG 𝟮 𝗵𝗼𝘂𝗿𝘀. 𝟰 𝗲𝘅𝗽𝗲𝗿𝘁𝘀. A 𝘀𝘁𝗿𝗼𝗻𝗴 𝗳𝗼𝗰𝘂𝘀 𝗼𝗻 𝗔𝗜 around regulatory affairs, clinical evaluation, technical documentation and eQMS. 🎯 𝗙𝗼𝗿 𝗥&𝗗, 𝗤𝗔/𝗥𝗔 𝗮𝗻𝗱 𝗽𝗿𝗼𝗷𝗲𝗰𝘁 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗽𝗿𝗼𝗳𝗲𝘀𝘀𝗶𝗼𝗻𝗮𝗹𝘀 looking for practical insights they can apply to their daily work. 𝗘𝘃𝗲𝗻𝘁 𝗗𝗲𝘁𝗮𝗶𝗹𝘀: 🗓️ Tuesday, September 22, 2026 🕒 15:00 - 17:00 CET 💻 Live online 🎙️ Presentations in English 👉 𝗝𝗼𝗶𝗻 𝘂𝘀 𝗮𝗻𝗱 𝘀𝗵𝗮𝗿𝗽𝗲𝗻 𝘆𝗼𝘂𝗿 𝘀𝗸𝗶𝗹𝗹𝘀! Register here: https://lnkd.in/eGsrynQy See you online! 🚀 #SharpenYourSkills #MedicalDevices #MedTech #MedicalDeviceDevelopment #AIinMedTech #ArtificialIntelligence #RegulatoryAffairs #ClinicalEvaluation #TechnicalDocumentation #eQMS #QARA #MedicalDeviceSoftware