Internal Audits – A Strategic Tool for Continuous Improvement
At GBA Key2Compliance, internal audits are more than a regulatory requirement. They are a proactive way to identify gaps, strengthen your quality system, and ensure you stay ahead of Notified Bodies and Competent Authorities. Our auditors bring deep regulatory knowledge and extensive hands-on industry experience. With expertise across MDR, IVDR, ISO 13485, and MDSAP, we […]
Meet us at Park Annual #20 2025
We’re excited to share that we’ll be on site as a partner at Park Annual #20 in Gothenburg on November 26, 2025, hosted by Sahlgrenska Science Park. This year’s program focuses on “Next Generation – Precision Medicine,” bringing together innovators, researchers, and industry leaders to explore future technologies and the evolving healthcare landscape. Our colleagues […]
Internal audits – an opportunity to improve Medical Devices
Internal audits are an important activity for medical device manufacturers. It is not only a requirement for ISO 13485 compliance, but also an opportunity to get valuable feedback that can help to improve both the medical device and the development process. At GBA Key2Compliance, our experienced auditors support clients throughout the entire internal audit process – ensuring compliance, […]