MentorMate’s Post

Feeling overwhelmed by the MDR and technical documentation for your Medical Device Software? 🤔 Join our free webinar this Thursday! Caroline will break down the MDR requirements, Notified Body selection, and qualification and classification process —all with your software’s Intended Purpose in mind. 🔍 Get the info you need to conquer technical documentation. 👉 Register now: https://lnkd.in/eXW7qKHX #MDSW #MDR #MedicalDeviceSoftware #TechnicalDocumentation

A glance at IEC 62304 - Standard for Medical Devices software (Software life cycle processes). This standard defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes. I have done a quick study and collected some key components into the mindmap. We plan to achieve this year - this looks super promising to our capabilities and our strategy. Digital Health by FPT Software (GHC)

Feeling overwhelmed by the MDR and technical documentation for your Medical Device Software? 🤔 Join our free webinar this Thursday! Caroline will break down the MDR requirements, Notified Body selection, and qualification and classification process —all with your software’s Intended Purpose in mind. 🔍 Get the info you need to conquer technical documentation. 👉 Register now: https://lnkd.in/eFHCkFTD #MDSW #MDR #MedicalDeviceSoftware #TechnicalDocumentation

FDA : Software Assurance guidance for Production and Quality Explore FDA's risk-based approach to ensure software reliability in medical device production. Learn testing methods for compliance in 21CFR part 820. Read more: https://lnkd.in/gyiXhjxs #FDAguidance #SoftwareAssurance #MedicalDevice #QualitySystems #RiskAnalysis #ComplianceTesting #RegulatoryCompliance #HealthTech #21CFRpart820 #FDAcompliance #SoftwareValidation

𝐈𝐒 𝐌𝐘 𝐒𝐎𝐅𝐓𝐖𝐀𝐑𝐄 𝐀 𝐂𝐋𝐀𝐒𝐒 𝐈 𝐌𝐄𝐃𝐈𝐂𝐀𝐋 𝐃𝐄𝐕𝐈𝐂𝐄? I still get this question and wanted to share with you this video we have made with Stefan Bolleininger and Oliver Hilgers I know that if your software is considered as a class I life would be easier for you. So we tried on this video to provide you with some tips on when you can make it a class I and when this is not possible. Don't miss this. https://lnkd.in/eaAHg66K #medicaldevice #regulatoryaffairs #samd #easymedicaldevice #medicalsoftware

Interested in the world of standards and regulations for Software used in Medical Devices? 💻🩺 Download this free whitepaper to learn more about the key definitions of medical device software, essential standards and regulations, including IEC 62304 and IEC 82304, and gain insights into future trends. Download it here: 👇 https://lnkd.in/eSwGUDA8 #Software #MedicalDevices #mdsw #IEC62304 #IEC82304

Interested in standards and regulations for Software used in Medical Devices? 💻🩺 This free whitepaper equips you with everything you need to know! Inside, you'll discover: - key definitions of medical device software and its scope. - A breakdown of essential standards and regulations, including IEC 62304 and IEC 82304, and how they work together. - Insights into future trends and main takeaways Download it here: 👇 https://lnkd.in/gP8c8Wxr #Software #MedicalDevices #mdsw #IEC62304 #IEC82304

Interested in standards and regulations for Software used in Medical Devices? 💻🩺 This free whitepaper equips you with everything you need to know! Inside, you'll discover: - key definitions of medical device software and its scope. - A breakdown of essential standards and regulations, including IEC 62304 and IEC 82304, and how they work together. - Insights into future trends and main takeaways Download it here 👉https://hubs.li/Q02CBXtZ0 #Software #MedicalDevices #mdsw #IEC62304 #IEC82304

Interested in standards and regulations for Software used in Medical Devices? 💻🩺 This free whitepaper equips you with everything you need to know! Inside, you'll discover: - key definitions of medical device software and its scope. - A breakdown of essential standards and regulations, including IEC 62304 and IEC 82304, and how they work together. - Insights into future trends and main takeaways Download it here: 👇 https://lnkd.in/e68aj2X8 #Software #MedicalDevices #mdsw #IEC62304 #IEC82304

A glance at IEC 62304 - Standard for Medical Devices software (Software life cycle processes). This standard defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes. I have done a quick study and collected some key components into the mindmap. We plan to achieve this year - this looks super promising to our capabilities and our strategy.