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What could your team achieve with AI as part of its everyday MedTech workflow? From drafting requirements and supporting risk analysis to reviewing documentation, large language models (LLMs) offer opportunities across the medical device lifecycle. Making them useful takes clear instructions, critical judgement and an understanding of responsible, compliant use. Our new course, Use of AI Power in Your Medical Device Lifecycle, helps you turn those possibilities into practice. Over two interactive half days, you’ll explore how to: • Identify where LLMs can add value in development, regulatory work, quality management and post market activities. • Write effective prompts and structure tasks for more reliable, useful outputs. • Apply AI to practical use cases, including requirements, risk analysis, test cases and document review. • Understand AI’s limitations and the governance needed to support compliant use. We’re organising this training in collaboration with Johner Institute, with Mario Klessascheck guiding you through practical exercises and medical device use cases. Designed for professionals in medical devices and IVDs working in development, quality assurance, regulatory affairs or product management. 📅 9 & 10 December 2026 | 09:00 to 12:30 CET each day | Online Bring your curiosity. Leave with practical approaches to AI that you can build on in your daily work. Explore the course and register: https://lnkd.in/d4ibp6_7

When can you truly say that a process is validated? In a GMP regulated environment, it is not enough for equipment, systems and processes to simply work. You need to be able to demonstrate that they perform as intended, consistently and reliably. But validation and qualification can quickly become complex. What should be validated? How much is enough? Where should you focus your efforts? And how do you make sure your approach meets regulatory expectations without creating unnecessary work? Our course Validation and Qualification is designed to help you see the bigger picture. Over two days, you will explore the principles behind qualification and validation, from regulatory expectations and risk based thinking to practical application of IQ, OQ, PQ and process validation. The goal? To help you make better decisions, focus your validation efforts where they matter most and build a strategy that works in practice. Because good validation is not about generating more documentation. It is about creating confidence in your processes. Date: November 25–26, 2026 Location: DGI Byen, Copenhagen Want to strengthen your approach to validation and qualification? Read more and register here: https://lnkd.in/diiExxJg

Last chance to register! Test Method Validation Made Easy Can you trust your test results? Unreliable measurement systems can lead to costly mistakes, rejected products and unnecessary quality issues. But identifying and fixing these problems doesn't have to be complicated. Join our two practical Test Method Validation (TMV) Made Easy webinars next week and learn how to evaluate, analyse and improve your measurement systems using simple statistical tools and graphical methods. Choose the webinar that suits your needs: 📅 20 October | 14:00–16:00 CET Part 1: Variable Measurements Learn how to evaluate measurement systems for numerical data. 📅 21 October | 14:00–16:00 CET Part 2: Attribute Measurements Learn how to evaluate measurement systems for pass/fail results. Each webinar is 2 hours long, with practical examples and a straightforward approach that makes statistical methods easier to understand and apply. No background in statistics is required, and you can attend either webinar independently or join both. ⏳ Only a few days left! Register now to secure your place.

Webinar: Is your AI software a medical device? AI is transforming healthcare, but understanding whether an AI solution qualifies as a medical device can be challenging. Join our free webinar to gain practical insights into the regulatory landscape for AI software and learn how to plan a clear path to market. Date & time: 29 October 2026, 13:00 to 13:45 CET Online and free of charge We will cover: • Medical device qualification of AI software • Software classification under the MDR and other regulations • Relevant regulations, guidance documents and standards • Regulatory strategy and market access planning • CE marking requirements • Key considerations for Quality, risk management and clinical evidence The webinar will be presented by Oscar He Lindholm, Client & Business Development Partner and AI expert at GBA Key2Compliance. Everyone who attends will also receive: 💡 Our practical guide, “Is Your Software a Medical Device?” 💬 The opportunity to book a complimentary 30-minute consultation with Oscar to discuss their software or regulatory questions. Whether you are developing a new AI solution or reviewing the regulatory status of existing software, this webinar will help you identify the right questions and plan your next steps. Register today to secure your place: https://lnkd.in/dTawJg6u

How do you maintain effective supplier control when outsourcing medical device activities? In this video, course instructor Ase Ek introduces the key questions you’ll explore in our two-day course. Selecting suppliers, defining responsibilities and managing changes can raise plenty of questions. What should a quality agreement cover? When is a supplier audit needed? And how do you build a strong partnership with your contract manufacturer? Our course Medical Device Supplier Control and Outsourcing explores these questions through practical tools and examples. Your instructors, Ase Ek and Tomas Camnell, will guide you through approaches to strengthen supplier selection, monitoring and collaboration throughout the product life cycle. We’ll cover: • Supplier selection and risk management • Quality agreements and responsibilities • Collaboration during development and design transfer • Supplier audits, ongoing monitoring and change management The course is designed for professionals involved in selecting, managing or working with suppliers in the medical device industry. Watch the video to hear Åse introduce the course and share what you can expect from the two days. 📅 17–18 November 2026 📍 DGI Byen, Copenhagen Build your knowledge and bring practical approaches back to your organisation. 👉 Read more and register: https://lnkd.in/dpnz3K3J

New to working in a GLP laboratory, or looking to refresh your knowledge of Good Laboratory Practice? Our Basic course in GLP gives you a practical introduction to the OECD Principles of GLP and what they mean for day-to-day work in a laboratory. You’ll explore roles and responsibilities within a GLP facility, study plans and reports, quality assurance, test items, data integrity and inspections. The course also introduces guidance you can turn to when you need more detail. The teaching draws on instructor Kristina Fant’s experience of setting up and working in a GLP laboratory for more than 10 years. The course is suitable for people new to GLP, those planning to establish a GLP facility and professionals who want to refresh their knowledge. No prior GLP knowledge is required. 8 October 2026, 09:00–17:00 CEST Online Instructor: Kristina Fant Learn more about the course and register below.