Medical Device HQ

Think #DesignControl is just a regulatory hoop to jump through? Think again. In this short video from Design Control course https://lnkd.in/epmH-y-X , Peter Sebelius explains the value of design control as best practices in developing new products. ❓ Do you agree? ❓ How has knowledge of design control changed your approach to product development? Leave your comment below 👇 #MedicalDevices #MedTech #ISO13485 ----------------------- 🟦 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.

Does design transfer apply to #SaMD? Please comment or choose your answer below. 💬 We'd love to hear your insights! #IEC62304 #MedTech  

📊 𝐒𝐚𝐟𝐞𝐭𝐲 𝐢𝐧 𝐫𝐢𝐬𝐤 𝐦𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐯𝐬. 𝐬𝐚𝐟𝐞𝐭𝐲 𝐢𝐧 𝐮𝐬𝐚𝐛𝐢𝐥𝐢𝐭𝐲 𝐞𝐧𝐠𝐢𝐧𝐞𝐞𝐫𝐢𝐧𝐠 There is a close connection between #RiskManagement according to #ISO14971, and usability engineering according to IEC 62366-1, which is confirmed by a flowchart in the IEC 62366-1 standard. Our usability engineering expert Dr. Michaela Kauer-Franz has included a simplified version of the flowchart below to aid the understanding. This graphic maps out how these processes work hand-in-hand to ensure device safety and usability. Learn more about usability engineering and risk management for medical devices in Dr Michaela Kauer-Franz’s video: https://lnkd.in/dphGzVvk #UsabilityEngineering #IEC62366 ------------------------ 🟦 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. #usability #usabilitytesting #medicaldevices

📢 New course dates! 10th & 11th Dec: Usability Engineering for Medical Devices blended course facilitated by Dr. Jonas Walter. Learn how to create intuitive, easy-to-use and safe medical devices with regulatory clearance according to IEC 62366-1:2020. The course starts with an introductory online course where you learn the theoretical foundations. You then get to apply this knowledge in the practical classroom sessions. You will write a use specification, work towards the first formative test, plan a summative study, and conduct a root cause analysis on the errors. With a maximum of 8 participants, there is ample opportunity for discussion and personalised answers from the expert. Participants will receive free templates and a course companion. Register today - click on the link below! #UsabilityEngineering #Training #MedicalDevices #BlendedLearning

🔍 Understanding the essentials of the #EUMDR PMS plan Post-Market Surveillance (PMS) is a critical aspect of ensuring medical devices remain safe and effective once they’re on the market. But what exactly must the PMS plan include according to the EU MDR? In this article, our EU MDR expert Pontus Gedda explains the key components: 💠 How to collect, utilise, and assess data 💠 Effective methods for investigating complaints and trend data 💠 References to procedures in the QMS  💠 Reference to the PMCF-plan 👉 Read the full article to ensure your PMS plan meets EU MDR standards: https://lnkd.in/dKaCkzth #MedicalDevices #PostMarketSurveillance #MDRCompliance ------------------------ 🟦 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.

💥 Last chance for up to €100 off on our Process Validation for Medical Devices course! (Discount ends Oct 31) https://lnkd.in/daMKvF4T Developed by our process validation expert Helena Hjälmefjord, this course is designed to simplify the complexities of process validation and help you build practical, essential skills—critical for compliance and efficiency in medical device production. Key topics include: ✅ Understand when and how to conduct process validation.  ✅ Learn key techniques and navigate common pitfalls.  ✅ Understand regulatory requirements and maintain your processes in a validated state.  ✅ Plan, perform, and revalidate processes using historical data.    👉 Discount ends Oct 31 – don’t miss out! #ProcessValidation #Medicaldevices #Medtech #QualityManagement 

💥 Last chance for up to €100 off on our Process Validation for Medical Devices course! (Discount ends Oct 31) https://lnkd.in/daMKvF4T Developed by our process validation expert Helena Hjälmefjord, this course is designed to simplify the complexities of process validation and help you build practical, essential skills—critical for compliance and efficiency in medical device production. Key topics include: ✅ Understand when and how to conduct process validation.  ✅ Learn key techniques and navigate common pitfalls.  ✅ Understand regulatory requirements and maintain your processes in a validated state.  ✅ Plan, perform, and revalidate processes using historical data.    👉 Discount ends Oct 31 – don’t miss out! #ProcessValidation #Medicaldevices #Medtech #QualityManagement 

What do you find most challenging in defining user needs and design inputs in medical device development❓   ⬇️ Full answer options: 1.     Clarifying user needs 2.     Translating needs into design inputs 3.     Managing changes during the project 4.     Differentiating between user needs and design inputs #requirementsengineering #userneeds #qsr

💡 AI systems in medical devices - what do you see as the future trend?   To clarify the complex landscape of AI in medical device software, our software expert Christian Kaestner has developed the following visual guide, focusing on the critical distinctions between locked systems and adaptive systems in medical devices. Currently, all medical device systems utilising AI are locked systems, which means their operational algorithms remain unchanged after their release. 👉 What do you see as the future trend for AI-based medical devices? Will we stay with locked systems or move toward adaptive AI? Share your thoughts below! #MedicalDevices #AI #MachineLearning ------------------------ 🟦 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.

📢 Upcoming course dates! 26th & 27th Nov: SaMD, IEC 62304 and IEC 82304-1 blended course facilitated by Christian Kaestner, member of the standardisation committees. Gain the knowledge and confidence to develop and maintain Software as a Medical Device (SaMD). The course starts with the introductory online course where you learn the theoretical foundations first, then you get to apply your knowledge in the practical classroom sessions. You'll engage in realistic tasks related to the software lifecycle in accordance with IEC 62304 and the product standard IEC 82304-1. With a maximum of 8 participants in the classroom, there is ample opportunity for discussion and personalised answers from the expert. Participants will receive free templates and a course companion. #Training #SaMD #MedicalDevices #BlendedLearning