TraceX

💥 A big thank you to TEAM-PRRC! 💥 I was really happy to present a webinar on how #AI-powered platforms are transforming efficiency in the medical device industry. Key highlights 🔥 1️⃣ Improving regulatory watch using your AI assistant. 2️⃣ Make your auditor happy with AI assistant search capabilities. 3️⃣ A game-changer for #consultants with the built-in AI assistant. 🔹 And many more ways to leverage AI within an all-in-one #automated platform like TraceX.co! 🔗 Want to watch this webinar and many others? Join the Team-PRRC community here: https://team-prrc.com/ Special thanks to Elem AYNE and Anne Jury for organizing and hosting this session! -- TraceX.co is a #free, #AI-powered #platform built to to manage the entire lifecycle of your medical device — from design to market launch, with full regulatory #compliance. ✨ Join the movement and create your #free workspace now 👉 https://lnkd.in/eAS5chum #free #eqms #medtech #healthtech #biotech #regulatory #iso13485 #iec62304 #projectmanagement #opensource #medicaldevice #AI #plm #collaboration

🎙Join our upcoming webinar 👉 How to integrate usability engineering in your medical device Project 📅 August 21st – 1:00 PM CET ➡️ Register here: https://lu.ma/r91eps07 🚀 Designing a #MedicalDevice? Regulatory compliance isn’t enough — your product also needs to be usable in real-world conditions. Join us for a live session with Amandine Broussier and Ilona Guiraud, usability engineering specialists from Usarea, as they share how to embed usability into your device development process — the right way. What you’ll learn: ✅ Why usability is essential for #safety and market success ✅ How to align with #IEC62366 throughout the lifecycle ✅ Common #pitfalls (and how to avoid them) ✅ Real examples + practical advice ✅ Live Q&A at the end 👩💼 Whether you’re in #QARA, #product development, #ClinicalAffairs, #humanFactors, or #UX — working in a #startup or part of an established #medtech team — if you’re building a medical device, this session is for you. 👉 Secure your spot now: https://lu.ma/r91eps07

🚀 Launching a medical device? You’ll need more than just a great product — you’ll need a rock-solid #QMS too. 🎥 The replay of our webinar with CSDmed is now live! Watch here → https://lnkd.in/e7x-Wqhj Guillaume Valenzuela (QARA consultant & ISO 13485 Lead Auditor) walks through a practical approach to building your first eQMS — aligned with #ISO 13485, #MDR, and #FDA requirements. ✅ What you’ll learn: • Common #pitfalls when setting up your QMS • A step-by-step #method that actually works • The importance of lifecycle thinking & #risk management • How TraceX (#free platform!) helps simplify your compliance work Ideal for #startups, #consultants, and #teams getting audit-ready. Let’s make compliance a little easier (and even fun 😉). --  PS: TraceX.co is a #free, #AI-powered #platform built to manage the entire lifecycle of your medical device — from design to market launch, with full regulatory #compliance. ✨ Join the movement and create your #free workspace now 👉 https://lnkd.in/eAS5chum

🎙️Webinar – How to integrate usability engineering in your medical device project Designing a medical device? Regulatory compliance isn’t enough, your product must also be safely usable in real-life conditions. Join us on August 21 at 1:00 PM (CET) for a live session hosted by Charles Rollet (TraceX), featuring Amandine and Ilona. We’ll cover: ✅ Why usability is key for risk reduction and market success ✅ How to align with IEC 62366 and embed it into your development lifecycle ✅ Common mistakes (and how to avoid them) ✅ Practical tips and real-world examples 📍Project leads, QARA specialists, startup founders and medtech teams working on CE or FDA compliance, this session is made for you. 🔗 Register here: https://lu.ma/r91eps07 Big thanks to Charles and TraceX for the invitation!

🚀 Big news for teams that need to be #compliant and #audit-ready. (e.g., #CE, #FDA, #ISO) 🔥 With TraceX.co, you can launch a #production-ready workspace in just #1click — fully configured, no setup delays, no dev support needed. 🔥 🚀 Here it is → https://lnkd.in/eAS5chum With just 1 click on that link, you get a complete workspace to manage: ✅ #Quality processes ✅ Technical #documentation ✅ Team #trainings ✅ Plus all the tools your team needs — from project management to real-time chat and video conferencing. We’re truly an all-in-one #platform, not just an #eQMS. For #consultants: you can use the same link to easily set up dedicated #workspaces for all your #clients. Our mission stays the same: make your #compliance as easy (and even fun) as possible — and do it for #free. — Built for #compliance, #free for your team. 🔥 Join the #revolution with #TraceX! #MedTech #RegTech #ComplianceMadeEasy

🤯 Tired of the chaos around #technicaldocumentation? Endless email threads. Conflicting versions. Long approval cycles. This video shows how TraceX.co changes that. From #drafting to approval, you’ll see how our #AI-powered platform helps your team create, review, and approve fully compliant documents — faster and with less stress. ✅ No more silos ✅ #AuditReady by design ✅ Free, #opensource, and built for #regulated industries 🎥 Let us show you what the future of #documentation looks like: https://lnkd.in/e9YXFEt8 --- Built for #compliance, #free for your team. 🔥 Join the #revolution with TraceX! #TraceX #Compliance #TechnicalDocs #ProductLifecycleManagement #AI #MedTech #Biotech #Automotive #Aerospace #RegTech

🎙Join our upcoming webinar 👉 How to integrate usability engineering in your medical device Project 📅 August 21st – 1:00 PM CET ➡️ Register here: https://lu.ma/r91eps07 🚀 Designing a #MedicalDevice? Regulatory compliance isn’t enough — your product also needs to be usable in real-world conditions. Join us for a live session with Amandine Broussier and Ilona Guiraud, usability engineering specialists from Usarea, as they share how to embed usability into your device development process — the right way. What you’ll learn: ✅ Why usability is essential for #safety and market success ✅ How to align with #IEC62366 throughout the lifecycle ✅ Common #pitfalls (and how to avoid them) ✅ Real examples + practical advice ✅ Live Q&A at the end 👩💼 Whether you’re in #QARA, #product development, #ClinicalAffairs, #humanFactors, or #UX — working in a #startup or part of an established #medtech team — if you’re building a medical device, this session is for you. 👉 Secure your spot now: https://lu.ma/r91eps07

🔵 Tip of the Day 🔵 What if your technical documentation could work for you? 💡 TraceX helps you go from draft to approved, audit-ready documentation — in record time. ✅ Automate your workflows with AI and built-in collaboration tools ✅ Ensure every doc meets CE, FDA, ISO requirements ✅ Free and open-source, tailored to regulated industries ✅ Supports your entire product lifecycle 🎥 Let us show you what the future of #documentation looks like: https://lnkd.in/e2JEktwe --- TraceX.co is a #free, #AI-powered #platform built to to manage the entire lifecycle of your medical device — from design to market launch, with full regulatory #compliance. ✨ Join the movement and create your #free workspace now 👉 https://lnkd.in/evCFAeJv #TraceX #eQMS #OpenSource #DigitalHealth #ProductLifecycle #AuditReady #QualityManagement #RegTech

🚀 Launching a medical device? You’ll need more than just a great product — you’ll need a rock-solid #QMS too. 🎥 The replay of our webinar with CSDmed is now live! Watch here → https://lnkd.in/e7x-Wqhj Guillaume Valenzuela (QARA consultant & ISO 13485 Lead Auditor) walks through a practical approach to building your first eQMS — aligned with #ISO 13485, #MDR, and #FDA requirements. ✅ What you’ll learn: • Common #pitfalls when setting up your QMS • A step-by-step #method that actually works • The importance of lifecycle thinking & #risk management • How TraceX (#free platform!) helps simplify your compliance work Ideal for #startups, #consultants, and #teams getting audit-ready. Let’s make compliance a little easier (and even fun 😉). --  PS: TraceX.co is a #free, #AI-powered #platform built to manage the entire lifecycle of your medical device — from design to market launch, with full regulatory #compliance. ✨ Join the movement and create your #free workspace now 👉 https://lnkd.in/eAS5chum

🚀 Big news for teams that need to be #compliant and #audit-ready. (e.g., #CE, #FDA, #ISO) 🔥 With TraceX.co, you can launch a #production-ready workspace in just #1click — fully configured, no setup delays, no dev support needed. 🔥 🚀 Here it is → https://lnkd.in/eAS5chum With just 1 click on that link, you get a complete workspace to manage: ✅ #Quality processes ✅ Technical #documentation ✅ Team #trainings ✅ Plus all the tools your team needs — from project management to real-time chat and video conferencing. We’re truly an all-in-one #platform, not just an #eQMS. For #consultants: you can use the same link to easily set up dedicated #workspaces for all your #clients. Our mission stays the same: make your #compliance as easy (and even fun) as possible — and do it for #free. — Built for #compliance, #free for your team. 🔥 Join the #revolution with #TraceX! #MedTech #RegTech #ComplianceMadeEasy