News - 2026-09-14 Click here to view in web MedTech News: Latest Insights and Key Updates It’s been an exciting period at GBA Key2Compliance – from insightful discussions at Park Annual #18 to meeting industry peers at both NLS Days and MedTechdagen. In this issue, we share highlights from recent events, dive into why internal audits are such a valuable tool, and offer guidance on key regulatory questions. You’ll also find a roundup of our latest expert articles and upcoming courses designed to support your work in MedTech. Scroll down to explore all the updates. We attended Park Annual #18 2025! Last week, we joined Park Annual at Sahlgrenska Science Park as a partner, where the theme “Next Generation – Precision Medicine” sparked discussions on future technologies and healthcare innovation. Our colleagues Johan Grahn and Lars Mentzer enjoyed meeting many of you to talk about innovation, regulatory pathways, and clinical challenges. Thank you for the inspiring conversations!  Audits don’t have to be scary – they’re a powerful tool for improvement. At GBA Key2Compliance, we view internal audits as a way to spot gaps, strengthen processes, and stay ahead. Our experienced auditors bring deep regulatory knowledge and hands-on industry expertise across MDR, IVDR, ISO 13485, and MDSAP. We offer everything from quick one-day audits to full Audit Service Agreements — always tailored to your needs. Want to learn more? Click the button down below. Internal Audit Services Internal audits – an opportunity to improve Medical Devices Internal audits don’t have to be something you “get through” – they can be one of your strongest tools for improvement. Read full blog Is Your Innovation a Medical Device? When developing something new - a device, software, or system - one of the biggest early questions is: Does this fall under the Medical Device Regulation (MDR)? Read full blog Have you missed our recent articles from the Clinical Development team? Over the past months, we’ve highlighted the people behind our work - sharing insights, experiences, and the everyday challenges of driving clinical studies forward. Here’s a recap of the articles in case you want to catch up: 🔹 Safety Data That Makes a Difference – Insights from Safety Manager Ida Björklund 🔹 What It Takes to Keep a Clinical Study Going – Meet Clinical Research Associates Ana Zamani and Susanna Hellström 🔹 Inside the Role of a Clinical Project Manager – Meet Anna Östblom 🔹 Why Less is More in Clinical Data – Insights from Senior Clinical Data Manager Åsa Testad 🔹 Simplifying IVDR Compliance: Insights from Senior Consultant Emily Malmberg Each article offers a unique perspective from our Clinical Development experts — the people who turn complex projects into successful outcomes. Feel free to explore the articles and get to know our team’s work more closely. Courses you may like: Medical Device Quality Management Systems Training Learn more Risk Management according to ISO 14971:2019 Learn more FMEA Without Tears Learn more Homepage  |  info@key2compliance.com | +46 8 621 05 02 Follow us This e-mail is sent to the above e-mail address and is intended for you as an executive and / or contact person with common business interests as we have. We handle your personal information to communicate with you, provide you with newsletters, for marketing communications and to maintain our business contacts. For information on how we collect, manage, use, share, store and protect your personal information read our Privacy Policy. Privacy policy - Personal information - Online marketing policy Subscribe  |  Unsubscribe