At Asphalion, we’re dedicating this week to highlighting the importance of MedTech. Our team of MedTech consultants, working in synergy with our pharmaceutical and scientific consultancy services, helps you stay ahead of market challenges while navigating regulatory and quality requirements.
🔎 Today, we’re putting the spotlight on AI in Medical Devices, with a closer look at the EU AI Act, ISO/IEC 42001, and EN 18286.
We’ll explore the EN 18286 timeline and key takeaways, why AI-enabled Medical Device Software (AI MDSW) may be classified as high-risk under the EU AI Act, the requirements applicable to high-risk AI systems, relevant standards, and much more.
Stay tuned for insights to help you navigate the evolving regulatory landscape for AI in medical devices!
Throughout the week, we’ll be sharing best practices, regulatory updates, and expert insights—including our webinar, “Clinical Data Exemptions for Software: What Evidence Does Your MDSW Really Need?”—alongside valuable resources to support your Medical Device Software (MDSW) development and compliance strategies.
Need help navigating your MedTech strategy? At Asphalion, we are committed to guiding you through each step of the regulatory pathway. Get in touch with us!: [email protected]
Check out our article here: AI in Medical Devices – MedTech Week
Register to our webinar “Clinical Data Exemptions for Software: What Evidence Does Your MDSW Really Need?“: https://bit.ly/4xRtjsf
