confinis’ Post

Re Crowdstrike issue: This is a classic example of why this form of supplier management, that is software composition analysis and validation as well as staying ahead of the suppliers of the packages you include is so important. It's also why validating patches is also important as a bad patch can lead to something like this. It's also why it's almost more important to have a good recovery plan as well as a prevention plan and procedures. It enables your customers to get back up and running with minimal disruption and minimal impact to patient safety. As your quality person, I am here to help you get on top of this, so your device or system does not further a situation like this. For startups, I'm here to help you ensure your idea is in fact safe from being used for something like this. With all of the software in and as medical devices, you need someone like me who speaks the languages of both software and medical device quality and regulatory. Please contact for more information!

Are you part of the MedTech Community? Are you coming to Boston Sept 25th-26th?? Let's connect regarding better insight, one source of truth, increased throughput and/or regulation! Stay tuned, more detail to come!! #BlueMountain #BlueMountainRAM #R4 #LifeScience #LifeScienceIndustry #GMP #GXP #21CFRPart11 #complianceregulations #meddevice #cmms software #predictive maintenance

Hello Connections, While auditing, sometimes it’s shocking to know when freedom is misused while developing a Software Medical device in alignment with QMS, as per ISO 13485 Clause 4.1.6. Classic scenario is, while developing MDSW, the COTS and SOUPs used may not be validated by the IT team, nor does the design team have enough patience to get it validated. Yeah, you guessed right, it’s popular in SMEs or startups. Another POV is, do the risk is analyzed or taken care to update the version of the COTS and SOUPs. ISMS – ISO 27001:2022 clearly states the access review and level of access freedom. Your suggestions are welcome

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🎙 𝐇𝐨𝐰 𝐭𝐨 𝐂𝐞𝐫𝐭𝐢𝐟𝐲 𝐚 𝐒𝐨𝐟𝐭𝐰𝐚𝐫𝐞 𝐚𝐬 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐰𝐢𝐭𝐡 𝐃𝐫. 𝐀𝐛𝐭𝐢𝐧 𝐑𝐚𝐝? (𝐓Ü𝐕 𝐒Ü𝐃) 🎙 Software as a Medical Device (SaMD) is a challenging and evolving field, especially within the EU Regulation framework. Unlike traditional medical devices, SaMD requires a nuanced approach since each software solution must be considered individually. In an Easy Medical Device Podcast episode, we invited Dr. @Abtin Rad from TÜV SÜD, a renowned expert in the field, to provide insights directly from a Notified Body. Dr. Rad discussed the complexities of SaMD certification, focusing on three key areas: ◼ SaMD Classification: Understanding the unique regulatory requirements for each software. ◼ Cybersecurity: Essential practices to safeguard patient data and device functionality. ◼ Artificial Intelligence: Addressing the specific challenges of integrating AI in medical devices. This episode is packed with valuable tips and warnings for anyone involved in the development and regulatory compliance of SaMDs. It's a must-listen for those navigating this intricate landscape! 🔗 Listen to the full episode here: https://lnkd.in/eEBXb7pn #MedicalDevices #SaMD #Cybersecurity #ArtificialIntelligence #RegulatoryAffairs #TÜVSÜD #EasyMedicalDevice #HealthcareInnovation #DigitalHealth #MedTech #HealthTech #SoftwareDevelopment #ClinicalSafety #AIinHealthcare #MedicalSoftware #Compliance

School administrators are taking notice of new technologies to provide better experiences for students and faculty. Learn about some of the latest news from the recent 1EdTech Consortium Digital Credential Summit with Indicio VP of Business Development James Schulte in the recent Identity Insights: https://lnkd.in/gawZC9PQ #SSI #digitaleducation #digitalidentity #decentralizedidentity #edtech #edtechinnovation

💻 Our webinar recording, 'Unlocking Innovation: Building Your Company's Patent and Technology Database with IamIP,' is now available! Revisit key insights from industry leaders Viktor Rudolf and Zack Amir as we delve into best practices for patent database creation and management. Gain perspectives into enhancing existing databases or starting from scratch. Watch here: https://lnkd.in/giU2Xbx5 #webinar #patentdatabase #patents #intellectualproperty

This whitepaper explains how to use the SOC-CMM to define and operationalise your target operating model, introduces the SOC-CMM SOCTOM tool, and provides best.

👋🏽 One day to go before our #OBIO-Mentor Works webinar where we'll be exploring the basics of SR&ED and overcoming technological uncertainty. Register now to learn about SR&ED eligibility with case studies highlighting work from early-stage research to scale-up and #commercialization.   https://lnkd.in/gH-Nj2Ap       #SRED #productdevelopment #clinicaltrials #taxcredits #scientificresearch  

Do you want to digitalize and innovate in your quality management processes? Do your ISO or GMP compliance operations require more automation and use of the latest technology to drive effiency? Join us on the 7th to learn how NORMA can help you acheive it in less than 12 weeks. #QMS #Compliance #SolEx #Stratesyssolutions #innovation #qualitydriven