Shiva Chaitanya Sampathi’s Post

RAPS Workshop: Software as a Medical Device (SAMD) March 2024 Monday, 18 Mar 2024 (09:00 AM) - Thursday, 21 Mar 2024 (01:00 PM) Eastern Time (US & Canada) Navigating the regulatory expectations for software-based products is particularly challenging and requires a specific approach. Join us for a review of the current and evolving global regulatory requirements affecting software as a medical device (SaMD). Our expert faculty will address both how to determine when software is categorized as a SaMD and how to correctly classify it under global requirements. Given that assessing risk for software is more challenging, attendees will use case studies to help them complete required evaluations. This interactive workshop will help regulatory and quality professionals develop the knowledge they need to help steer their organizations in the right direction when it comes to global SaMD expectations. Technical staff will get a better understanding of how to translate regulatory expectations into concrete design and development. Organizational leaders will gain strategic knowledge that will increase the likelihood of gaining green lights from regulators and better strategize their development program.

🚩 It's time to say goodbye to Word files for managing clinical evaluations in the MedTech industry. Working closely with a range of MedTech companies, from small startups to enterprise companies, I've noticed a common inefficiency: reliance on Word documents for critical documentation. At least since the Medical Device Regulation (#mdr), this dependency has become a significant hurdle. Consider this: crucial information like the intended purpose of a #medicaldevice is scattered across numerous documents - CEP, CER, PMCF plan, PMCF report, PMS plan, PSUR, the SSCP, and many more. Updating this information manually across multiple documents is not just time-consuming but also prone to errors. 💣 The worst-case scenario is that the manufacturer maintains an Excel spreadsheet with an overview of all documents that include the intended purpose statement to "facilitate" this update. This is okay when you only have to deal with one or two devices. But otherwise, you waste the resources of many intelligent brains. I know many manufacturers are hesitant to invest in digital solutions such as electronic records management systems because of the costs involved. 🤔 But imagine a world where we could again focus on the really important things (e.g., analyzing the data in the CER) instead of copying and pasting information from one document to the other. #medicaldevices #regulatoryaffairs #digitalinnovation #mdr #DeclutterRegulatoryDocumentation #medicalwriting

𝗖𝗗𝗥𝗛 𝗟𝗲𝗮𝗿𝗻 has just rolled out some fresh updates, and it's worth taking a look if you're in the medical device field. Among the highlights is the 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗦𝘁𝗲𝗿𝗶𝗹𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝗧𝗼𝘄𝗻 𝗛𝗮𝗹𝗹 𝗦𝗲𝗿𝗶𝗲𝘀, which can be found in the 𝗦𝗽𝗲𝗰𝗶𝗮𝗹𝘁𝘆 𝗧𝗲𝗰𝗵𝗻𝗶𝗰𝗮𝗹 𝗧𝗼𝗽𝗶𝗰𝘀 section. Among other things, it covers the recent updates to the final guidance titled 𝗦𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻 𝗮𝗻𝗱 𝗥𝗲𝘃𝗶𝗲𝘄 𝗼𝗳 𝗦𝘁𝗲𝗿𝗶𝗹𝗶𝘁𝘆 𝗜𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻 𝗶𝗻 𝗣𝗿𝗲𝗺𝗮𝗿𝗸𝗲𝘁 𝗡𝗼𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 (𝟱𝟭𝟬(𝗸)) 𝗦𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻𝘀 𝗳𝗼𝗿 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 𝗟𝗮𝗯𝗲𝗹𝗲𝗱 𝗮𝘀 𝗦𝘁𝗲𝗿𝗶𝗹𝗲 (https://lnkd.in/eBgnZ-Er). Other interesting recent updates to the learning platform include: ⏺ 𝗤𝘂𝗮𝗹𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗧𝗼𝗼𝗹𝘀: 𝗙𝗶𝗻𝗮𝗹 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 ⏺ 𝗔𝘀𝘀𝗲𝘀𝘀𝗶𝗻𝗴 𝘁𝗵𝗲 𝗖𝗿𝗲𝗱𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗼𝗳 𝗖𝗼𝗺𝗽𝘂𝘁𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗠𝗼𝗱𝗲𝗹𝗶𝗻𝗴 𝗮𝗻𝗱 𝗦𝗶𝗺𝘂𝗹𝗮𝘁𝗶𝗼𝗻 𝗶𝗻 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗦𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻𝘀: 𝗙𝗶𝗻𝗮𝗹 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 For direct access to these updates and more, visit 𝗖𝗗𝗥𝗛 𝗟𝗲𝗮𝗿𝗻: https://lnkd.in/eiiytw3. #MedicalDeviceRegulation #FDA #CDRHLearn #SterilizationGuidance #HealthTech

Software as a Medical Device (SaMD) is increasingly transforming medicine and healthcare, with more and more organisations setting out to implement these solutions. However, SaMD development comes with various challenges which is why there are a few key considerations to keep in mind. Discover what they are in my colleague’s article and find out how to create SaMD solutions that deliver lasting impact!

Software as a Medical Device (SaMD) is increasingly transforming medicine and healthcare, with more and more organisations setting out to implement these solutions. However, SaMD development comes with various challenges which is why there are a few key considerations to keep in mind. Discover what they are in my colleague’s article and find out how to create SaMD solutions that deliver lasting impact!

Medical: Software as a Medical Device (SaMD) Q&A Software as a Medical Device (SaMD) is quickly emerging as one of the top innovations in the healthcare industry. Manufacturers are looking to integrate this into their solutions to improve patient outcomes -- something we can all appreciate and support. SaMD includes diagnostic apps, software for patient monitoring, and treatment planning tools that have the potential to prevent, diagnose, treat, or mitigate a disease or condition. The more apps that support devices, the further SaMD will evolve. And of course there are growing regulations to ensure the safety, quality, and reliability of this software. If you want to learn more, I suggest downloading: Q&A on Software As A Medical Device (SaMD) Harness the power of innovation with our latest Q&A article on Software as a Medical Device (SaMD). Discover how Intertek's expert services can navigate you through the complex landscape of SaMD compliance, ensuring that your software not only meets rigorous regulatory standards but also enhances patient safety and data security. Download now to stay ahead in the rapidly evolving world of medtech and ensure your SaMD solutions are effective and reliable. https://lnkd.in/dmQP5tX5

𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐒𝐨𝐟𝐭𝐰𝐚𝐫𝐞: 𝐂𝐨𝐧𝐬𝐢𝐝𝐞𝐫𝐚𝐭𝐢𝐨𝐧𝐬 𝐟𝐨𝐫 𝐃𝐞𝐯𝐢𝐜𝐞 𝐚𝐧𝐝 𝐑𝐢𝐬𝐤 𝐂𝐡𝐚𝐫𝐚𝐜𝐭𝐞𝐫𝐢𝐳𝐚𝐭𝐢𝐨𝐧 (𝐈𝐌𝐃𝐑𝐅/𝐒𝐚𝐌𝐃 𝐖𝐆/𝐍81 𝐃𝐑𝐀𝐅𝐓: 2024) - 29 𝐉𝐚𝐧𝐮𝐚𝐫𝐲 2024 ▶️ 𝐒𝐨𝐟𝐭𝐰𝐚𝐫𝐞 𝐩𝐥𝐚𝐲𝐬 𝐚𝐧 𝐢𝐧𝐜𝐫𝐞𝐚𝐬𝐢𝐧𝐠𝐥𝐲 𝐜𝐫𝐢𝐭𝐢𝐜𝐚𝐥 𝐫𝐨𝐥𝐞 𝐢𝐧 𝐡𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞, 𝐰𝐢𝐭𝐡 𝐚 𝐰𝐢𝐝𝐞 𝐫𝐚𝐧𝐠𝐞 𝐨𝐟 𝐩𝐫𝐨𝐝𝐮𝐜𝐭𝐬 𝐬𝐞𝐫𝐯𝐢𝐧𝐠 𝐚 𝐯𝐚𝐫𝐢𝐞𝐭𝐲 𝐨𝐟 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐚𝐧𝐝 𝐚𝐝𝐦𝐢𝐧𝐢𝐬𝐭𝐫𝐚𝐭𝐢𝐯𝐞 𝐩𝐮𝐫𝐩𝐨𝐬𝐞𝐬 𝐢𝐧 𝐚 𝐫𝐚𝐧𝐠𝐞 𝐨𝐟 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐨𝐫 𝐩𝐫𝐢𝐯𝐚𝐭𝐞 𝐬𝐞𝐭𝐭𝐢𝐧𝐠𝐬. ▶️ 𝐀 𝐬𝐮𝐛𝐬𝐞𝐭 𝐨𝐟 𝐬𝐨𝐟𝐭𝐰𝐚𝐫𝐞 𝐭𝐡𝐚𝐭 𝐢𝐬 𝐮𝐬𝐞𝐝 𝐢𝐧 𝐡𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐢𝐬 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐞𝐝 𝐚𝐬 𝐚 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞 𝐠𝐥𝐨𝐛𝐚𝐥𝐥𝐲 𝐛𝐲 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐚𝐮𝐭𝐡𝐨𝐫𝐢𝐭𝐢𝐞𝐬. ⭕️ The objective of this document is to promote and inform clear and accurate characterizations of medical device software (including intended use/intended purpose statements) and introduce a general strategy for characterizing software-specific risks that leverages the key features of a comprehensive medical device software characterization. ⭕️ This document applies to the subset of software that meets the definition of a medical device (referred to throughout as medical device software), including software that meets the definition of Software as a Medical Device (SaMD) as is defined in the document, IMDRF SaMD WG N10 Software as a Medical Device: Key Definitions. #𝐈𝐌𝐃𝐑𝐅 #𝐒𝐚𝐌𝐃 #𝐌𝐞𝐝𝐢𝐜𝐚𝐥𝐃𝐞𝐯𝐢𝐜𝐞𝐒𝐨𝐟𝐭𝐰𝐚𝐫𝐞 #𝐈𝐌𝐃𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐬𝐟𝐨𝐫𝐦 #𝐌𝐞𝐝𝐢𝐜𝐚𝐥𝐃𝐞𝐯𝐢𝐜𝐞𝐖𝐨𝐫𝐤𝐢𝐧𝐠𝐆𝐫𝐨𝐮𝐩

Software as a Medical Device (SaMD) is increasingly transforming medicine and healthcare, with more and more organisations setting out to implement these solutions. However, SaMD development comes with various challenges which is why there are a few key considerations to keep in mind. Discover what they are in my colleague’s article and find out how to create SaMD solutions that deliver lasting impact!

Software as a Medical Device (SaMD) is increasingly transforming medicine and healthcare, with more and more organisations setting out to implement these solutions. However, SaMD development comes with various challenges which is why there are a few key considerations to keep in mind. Discover what they are in my colleague’s article and find out how to create SaMD solutions that deliver lasting impact!

Software as a Medical Device (SaMD) is increasingly transforming medicine and healthcare, with more and more organisations setting out to implement these solutions. However, SaMD development comes with various challenges which is why there are a few key considerations to keep in mind. Discover what they are in my colleague’s article and find out how to create SaMD solutions that deliver lasting impact!