Coauthor

🔎 MedTech Teams: What’s Your Biggest Software Supply Chain Challenge? With just 1 day to go until Part 2 of our Cybersecurity Webinar Series, we want to hear from you! 📢 When it comes to medical device software supply chains, what’s your biggest concern? 🔘 Keeping track of third-party components and open-source software 🔘 Ensuring SBOMs (Software Bill of Materials) are complete and up to date 🔘 Mitigating security vulnerabilities in SOUP 🔘 Aligning with updated regulations without slowing down development Drop your answer below and share your thoughts in the comments! Let’s get the conversation started before the webinar. 📅 Join us tomorrow, March 20th, as we tackle these challenges head-on with industry experts. #SaMD #MedicalDevices #RegulatoryCompliance #Cybersecurity #SBOM #SOUP #MedTech

We're returning to the MED-Tech Innovation Expo in June. Who else is coming? Register here: https://lnkd.in/eBpKQC3d #MedTechExpo2025

Happy St. Patrick’s Day from Coauthor! ☘️ A day for celebration, connection, and maybe even a little bit of luck. Whether you’re taking a well-earned break or deep in the world of MedTech and regulatory challenges, we hope today brings a moment to reflect on progress, collaboration, and what’s ahead. At Coauthor, we know that success in medical device software isn’t down to luck, it’s built on expertise, the right tools, and a commitment to doing things properly. But today, we’ll celebrate those moments of clarity and breakthroughs that make the journey worthwhile. 💬 What’s a key lesson or insight that has shaped your work in MedTech? Let’s hear it in the comments! #StPatricksDay #MedTech #SaMD #MedicalDevices #RegulatoryCompliance #DigitalHealth #QualityManagement

🚨 The Hidden Risks in Medical Device Software – Are You Prepared? 🚨 Medical device software isn't built in isolation. It relies on third-party components, open-source libraries, and constant regulatory updates that can introduce both opportunities and risks. But how much visibility do you really have over your software supply chain? 🔎 Can you confidently track every component in your SaMD? ⚠️ Would you know if a vulnerability was discovered in one of them? 📑 Are you leveraging SBOMs effectively to meet regulatory expectations? These aren’t just theoretical questions, they determine whether your product remains compliant, secure, and in the market. On March 20th, we're breaking down: ✅ What an SBOM (Software Bill of Materials) is and how it differs from SOUP ✅ The major components of an SBOM and how to generate one effortlessly ✅ How leading MedTech teams are using SBOMs to monitor vulnerabilities and reduce supply chain risks 💡 Still have questions? Our expert panel is here to answer them LIVE. 📅 Register now and take control of your software supply chain security. #SaMD #SoftwareSupplyChain #SBOM #SOUP #MedicalDevices #RegulatoryCompliance #MedTech

Regulations are advancing, expectations are rising, and medical device software teams are under more pressure than ever. But here’s the truth, compliance shouldn’t be a bottleneck. The best teams turn it into a competitive edge. 🔍 How do you keep up with shifting regulatory landscapes without slowing down? 💡 What’s one compliance challenge you wish had an easier solution? Let’s spark a conversation. Drop your thoughts in the comments! And if your team is tackling supply chain risks in medical device software, don’t miss our March 20th webinar. #MedTech #SaMD #RegulatoryCompliance #MedicalDevices #SoftwareDevelopment #QualityManagement

Too often, regulatory requirements feel like isolated hurdles rather than part of a streamlined development workflow. But the most successful teams don’t treat compliance as a final step, they embed it into their processes from day one. 🔹 How can regulatory alignment become a seamless part of development? 🔹 What’s holding teams back from achieving this? Let’s talk about real solutions that reduce compliance burdens without slowing progress. And if your team is tackling software supply chain risks, don’t miss our March 20th webinar where we’ll cover SBOMs, SOUP, and how to stay ahead of emerging vulnerabilities. #SaMD #RegulatoryCompliance #MedicalDevices #MedTech #SoftwareDevelopment #QualityManagement

Regulatory changes never stop. For MedTech teams developing Software as a Medical Device (SaMD), adapting to shifting standards isn’t just another box to check, it’s the difference between leading the industry and scrambling to keep up. Take the new UK guidance on Digital Mental Health Technologies. It’s yet another reminder that regulators are sharpening their focus on software safety and real-world impact. But instead of seeing compliance as an obstacle, it can be your team’s biggest advantage. The reality? Regulations change because technology does. The more MedTech moves toward real-time data processing, and patient-centric digital tools, the more important it is to guarantee quality, security, and transparency. Whether it’s MHRA, FDA, or EU MDR, these updates aren’t just rules to follow, they’re frameworks that support patient safety, build trust, and streamline product development. 🔍 How does your team stay ahead of compliance changes? 🔍 What’s been your biggest challenge in adapting to new regulations? Let’s keep the conversation going. Drop your thoughts in the comments, your experience might help another team find their best path forward. #SaMD #RegulatoryCompliance #MedicalDevices #DigitalHealth #SoftwareDevelopment #QualityManagement #MHRA #MDR #FDA

For SaMD teams, compliance isn’t just a one-time effort, it’s a continuous process that evolves alongside shifting regulations. Standards like IEC 62304, ISO 13485, and FDA requirements are constantly being updated, and staying ahead of these changes can feel like trying to hit a moving target. The challenge isn’t just understanding new requirements but integrating them efficiently without disrupting development timelines. Many teams struggle with outdated documentation processes, leading to last-minute compliance scrambles and delays in approvals. This is where having a proactive compliance strategy makes all the difference. By embedding compliance into your development lifecycle from the start, you can avoid the chaos of reactive documentation and ensure your product is always audit-ready. At Coauthor, we help teams manage compliance dynamically, keeping regulatory files up to date in real-time and reducing the burden of manual tracking. Because when compliance is streamlined, teams can focus on what matters, building safe medical software. How does your team stay on top of evolving regulations? Let’s discuss in the comments. #SaMD #MedicalDevices #RegulatoryUpdates #ComplianceMatters #MedTech #QualityManagement

For Software as a Medical Device (SaMD) teams, regulatory documentation is one of the most time-consuming aspects of development. Every requirement, design decision, risk assessment, and test result needs to be recorded, structured, and audit-ready. But with ever-changing regulations and global standards, maintaining compliance can feel like a never-ending task. The real challenge isn’t just generating documentation, it’s keeping it consistent, traceable, and aligned with shifting compliance requirements. Teams often find themselves caught between the demands of development speed and the meticulous nature of regulatory reporting. Without the right tools, this process can drain resources and slow down progress. At Coauthor, we help MedTech teams simplify compliance by embedding documentation directly into their workflow. Instead of retroactively compiling regulatory files, teams can support traceability and audit readiness from day one. The result? Faster approvals, reduced risk, and more time spent on innovation rather than paperwork. How does your team handle regulatory documentation? Let’s discuss best practices in the comments. #SaMD #RegulatoryCompliance #MedicalDevices #SoftwareDevelopment #MedTech #QualityManagement

Regulatory compliance isn't just about ticking boxes, it’s about making sure that Software as a Medical Device (SaMD) is safe and ready for real-world use. For developers, staying ahead of changing global regulations can feel like chasing a moving target, but getting it right means more than just approval, it means trust. When clinicians and regulators see a well-documented, risk-assessed, and validated SaMD product, they see reliability. That trust isn’t just a regulatory requirement, it’s what makes adoption easier, partnerships stronger, and market entry smoother. At Coauthor, we’re here to make compliance part of the development process, not an afterthought. Whether it’s keeping up with evolving MDR guidelines, ensuring audit-readiness for the FDA, or integrating risk management frameworks like ISO 14971, we help teams stay ahead, without slowing them down. How is your team approaching regulatory compliance? Let’s talk about it in the comments. #SaMD #MedicalDevices #RegulatoryCompliance #SoftwareDevelopment #HealthcareTechnology #MedicalSoftware