Medical Device HQ

We’re excited to launch our new course - #ISO13485 Internal Auditor Training, created by Peter Sebelius! 🎉 This course was designed with one clear goal: To provide the most practical and comprehensive training on ISO 13485 Internal Auditing. Whether you’re conducting internal or supply chain audits, or want to deepen your understanding of the standard, this course offers clear guidance. During validation, participants consistently highlighted these aspects: • "Concrete, representative examples for ISO 13485 internal auditing." • "Peter is great at simplifying complex concepts." • "Definitely the best ISO 13485 course I've taken—graphics and quizzes made learning so effective!" A heartfelt thank you to all the course validators: Edward B., Dr. Alfonso Otaegui, Gayathri Sumesh Nair, Ivan Tving, Jan Nowak, Jenny Völger, Johannes Hollensberg, Johannes Wolfert, Karl Bishop, Katarzyna Gonera, Klaus Bang Andersen, Lola Furlong, Michael Imlach, Rebecca Andrew, Soziar Bamyr Hanssen, Stephen Reeder, Tom Russel. We are grateful for the time and effort each of you put into that helped us improve the course and learning experience!    ✨ Special Launch discounts are available the launch month. Learn more and secure your spot: https://lnkd.in/dbXRXVrD #MedicalDevices #RegulatoryCompliance  ------------------------ 🟦 Medical Device HQ specialises in expert-led, practical training for the medical device industry. 🌍 Trusted by over 10,000 professionals globally. 📚 Explore our full training catalogue: https://lnkd.in/daBhgarC 👆 Follow us for expert insights, practical tips, and tools.

🔍 𝐌𝐨𝐧𝐢𝐭𝐨𝐫𝐢𝐧𝐠 𝐓𝐫𝐞𝐧𝐝𝐬 𝐢𝐧 𝐑𝐞𝐯𝐚𝐥𝐢𝐝𝐚𝐭𝐢𝐨𝐧 𝐟𝐨𝐫 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬 As the medical device industry evolves, it’s crucial to stay ahead of the curve when it comes to process validation and revalidation. Helena Hjälmefjord delves into how manufacturers can effectively monitor trends to stay compliant. Key takeaways: 💠Understand the timing and triggers for revalidation. 💠Identify emerging trends in process validation, such as new regulations or technological advancements. 💠 Monitor and adjust your validation process to stay compliant without overburdening your resources. 📈 Stay ahead by adapting to trends and ensuring that your processes remain validated to meet both current and future requirements. 🔗 If you haven’t already, read the full article here: https://lnkd.in/dCFgNyHC #ProcessValidation #MedTech #QualityManagement ------------------------ 🟦 Medical Device HQ specialises in expert-led, practical training for the medical device industry. 🌍 Trusted by over 10,000 professionals globally. 📚 Explore our full training catalogue: https://lnkd.in/daBhgarC 👆 Follow us for expert insights, practical tips, and tools.

🛠️ #UsabilityEngineering 𝐢𝐧 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞𝐬: 𝐒𝐚𝐟𝐞𝐭𝐲 𝐯𝐬 𝐬𝐢𝐦𝐩𝐥𝐢𝐜𝐢𝐭𝐲 When designing medical devices, there’s always a fine line between making a device intuitive for users and ensuring it’s safe. On one hand, Usability Engineering aims to create a device that is easy to use, reducing user errors, and improving patient outcomes. ❓ But does good usability always equal safety❓ Where do you draw the line between making a device intuitive and maintaining the highest safety standards? ⬇️ Share your thoughts! 🔗 Want more insights? Don’t miss Dr. Michaela Kauer-Franz's article on usability engineering and risk management in medical devices: https://lnkd.in/dXewG-kX #usability #usabilitytesting #medicaldevices ------------------------ 🟦 Medical Device HQ specialises in expert-led, practical training for the medical device industry. 🌍 Trusted by over 10,000 professionals globally. 📚 Explore our full training catalogue: https://lnkd.in/daBhgarC 👆 Follow us for expert insights, practical tips, and tools.  

🚀 𝐓𝐨𝐩 𝟑 𝐌𝐮𝐬𝐭-𝐖𝐚𝐭𝐜𝐡 𝐕𝐢𝐝𝐞𝐨𝐬 𝐨𝐧 𝐎𝐮𝐫 𝐘𝐨𝐮𝐓𝐮𝐛𝐞 𝐂𝐡𝐚𝐧𝐧𝐞𝐥 These top 3 videos of 2024 are still essential for anyone in the medical device industry. If you haven’t seen them yet, now’s the perfect time to catch up and stay informed: 1️⃣ Design Control for Medical Devices - Online introductory course -> Learn the key principles and best practices for implementing design control in your medical device development process. 2️⃣ Risk management for medical devices and ISO 14971 - Online introductory course -> Discover how to manage risks effectively in the medical device lifecycle and ensure compliance with ISO 14971. 3️⃣ Short course on the Medical Device Regulation (EU) 2017/745 -> Gain insights into the latest MDR requirements and how to navigate the regulatory landscape for medical devices in the EU. 📺 Catch them all here: https://lnkd.in/dKc_MPsZ What video would you love to see next❓ Drop your suggestions in the comments! ⬇️ #RegulatoryCompliance #riskmanagement #iso14971 #eumdr ------------------------  🟦 Medical Device HQ specialises in expert-led, practical training for the medical device industry. 🌍 Trusted by over 10,000 professionals globally.  📚 Explore our full training catalogue: https://lnkd.in/daBhgarC 👆 Follow us for expert insights, practical tips, and tools.

Turn usability theory into practice - join our blended course this May! Want to develop intuitive, easy-to-use, and safe medical devices that meet regulatory requirements? Join our Blended Usability Engineering Course, facilitated by Dr. Jonas Walter, and learn how to implement IEC 62366-1:2020 compliance in a hands-on setting in collaboration with Medical Device HQ. 📚 How it works: 🔹 Start with an online course from me where you'll learn the theoretical basics of usability engineering. 🔹 Apply your knowledge afterwards in an interactive live classroom sessions on 7-8 May, led by Dr. Jonas Walter (max. 8 participants). What's included: ✅ Introduction to Usability Engineering and IEC 62366-1 online course with lifetime access ✅ Two live classroom sessions on 7-8 May (13:00–16:30 CET) via Zoom, led by Dr Jonas Walter. Max 8 participants. ✅ Electronic course companion ✅ Free premium templates ✅ Course certificate worth 23 CPD points Book your seat now! Click on the link below. https://lnkd.in/eh4MefNQ

📢 New course dates: 6th & 7th May: 𝐃𝐞𝐬𝐢𝐠𝐧 𝐂𝐨𝐧𝐭𝐫𝐨𝐥 𝐟𝐨𝐫 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬 blended course facilitated by Helena Hjälmefjord. Learn about the big picture and become more confident in applying design control for medical devices. What's included: ✅ Introduction to Design Control for Medical Devices online course with lifetime access created by Peter Sebelius ✅ Two live classroom sessions on 6th & 7th May (13:00–16:30 CET) via Zoom, led by Helena Hjälmefjord. Max 8 participants. ✅ Electronic course companion ✅ Free premium templates ✅ Course certificate worth 24 CPD points Book your seat now! Click on the link below: https://lnkd.in/dEMiDSre #designcontrol #training #medicaldeviceindustry #blendedlearning

𝐔𝐧𝐝𝐞𝐫𝐬𝐭𝐚𝐧𝐝𝐢𝐧𝐠 #𝐈𝐒𝐎𝟏𝟑𝟒𝟖𝟓 𝐢𝐬 𝐨𝐧𝐞 𝐭𝐡𝐢𝐧𝐠—𝐚𝐩𝐩𝐥𝐲𝐢𝐧𝐠 𝐢𝐭 𝐢𝐧 𝐫𝐞𝐚𝐥-𝐰𝐨𝐫𝐥𝐝 𝐩𝐫𝐨𝐜𝐞𝐬𝐬𝐞𝐬 𝐢𝐬 𝐚𝐧𝐨𝐭𝐡𝐞𝐫. If you work in quality, regulatory, R&D, or product development, you know how challenging it can be to work with the standard in daily operations. 💡 That’s exactly what the Quality Management Blended Course is designed for—structured, hands-on training on applying ISO 13485, with a self-paced online course by Peter Sebelius, and 2 expert-led classroom sessions by Pontus Gedda. 𝐖𝐡𝐨 𝐢𝐬 𝐭𝐡𝐢𝐬 𝐟𝐨𝐫? ✅ Quality professionals & those involved in QA-related tasks. ✅ Anyone new to ISO 13485 who wants structured, hands-on training to translate ISO 13485 into effective operational processes.   ✅ Anyone supporting QA functions 💡 𝐖𝐡𝐚𝐭 𝐦𝐚𝐤𝐞𝐬 𝐭𝐡𝐢𝐬 𝐜𝐨𝐮𝐫𝐬𝐞 𝐝𝐢𝐟𝐟𝐞𝐫𝐞𝐧𝐭? 🔹 Blended format – Online theory + live virtual classroom sessions for direct expert interaction. 🔹 Practical case studies & workshops 🔹 Time-saving templates & resources 📅 June 10-11 | 1PM - 4:30PM CET 🔗 Sign up here: https://lnkd.in/d6NUUHHT ⏳ Only 8 seats! Classroom sessions scheduled just 1-2 times a year—grab yours before it's gone! #MedicalDevices #RegulatoryCompliance #QualityManagement ------------------------  🟦 Medical Device HQ specialises in expert-led, practical training for the medical device industry. 🌍 Trusted by over 10,000 professionals globally.  📚 Explore our full training catalogue: https://lnkd.in/daBhgarC 👆 Follow us for expert insights, practical tips, and tools.

📢 For everyone working with medical device software—how does your team handle Agile? Do you follow Agile fully, mix it with waterfall, or find compliance too challenging? Vote below and let’s see how teams are approaching it! 👇 #MedicalDevices #IEC62304

A heartfelt thank you to Ariadna N. for sharing her experience after completing #ISO14155 expert Maria Nyåkern’s clinical investigation course! #clinicaltrials #clinicalstudies #clinicalresearch ------------------------  🟦 Medical Device HQ specialises in expert-led, practical training for the medical device industry. 🌍 Trusted by over 10,000 professionals globally.  📚 Explore our full training catalogue: https://lnkd.in/daBhgarC 👆 Follow us for expert insights, practical tips, and tools.

📹 Medical Device Talks new episode : 𝐇𝐨𝐰 𝐝𝐨 𝐲𝐨𝐮 𝐢𝐧𝐭𝐞𝐠𝐫𝐚𝐭𝐞 𝐚𝐧 𝐨𝐟𝐟-𝐭𝐡𝐞-𝐬𝐡𝐞𝐥𝐟 𝐩𝐨𝐰𝐞𝐫 𝐬𝐮𝐩𝐩𝐥𝐲 𝐰𝐡𝐢𝐥𝐞 𝐦𝐞𝐞𝐭𝐢𝐧𝐠 𝐈𝐄𝐂 𝟔𝟎𝟔𝟎𝟏-𝟏 𝐫𝐞𝐪𝐮𝐢𝐫𝐞𝐦𝐞𝐧𝐭𝐬?   Join Peter Sebelius and Claus Rømer Andersen as they break down the key challenges and best approaches for ensuring compliance. #medicaldevices #MedTech #IEC60601 ------------------------ 🟦 Medical Device HQ specialises in expert-led, practical training for the medical device industry. 🌍 Trusted by over 10,000 professionals globally. 📚 Explore our full training catalogue: https://lnkd.in/daBhgarC 👆 Follow us for expert insights, practical tips, and tools.