See us at MedTechDagen 25 September!
GBA Key2Compliance is proud to be a partner of MedTechdagen and we look forward to being on-site when the industry’s leading companies, researchers, and decision-makers gather to discuss the future of medical technology, innovations, and regulatory challenges. At the same time, Medtech Magazine is celebrating its 20th anniversary, making this event even more special. Take […]
Developing Medical Device Software: Essential Insights for Founders
Claudia DannehlSenior consultant, Medical Device RA – GBA Key2Compliance Many software development companies fear the classification of their software as a medical device, because developing a medical device means following many regulations. However, there are also few advantages to having software applications that qualify as medical device software (MDSW). In this blog post, we aim […]
Outsourcing Internal Audits in MedTech: Strategic Advantage or Regulatory Risk?
Nadia Ragnvald Caspersen Senior consultant, Medical Device QA – GBA Key2Compliance In the medical device industry, internal audits are a vital part of maintaining compliance, ensuring product safety, and preparing for regulatory inspections. But as companies face increasing complexity, limited resources, and the pressure of unannounced audits, many are asking: Is it acceptable to outsource […]
GAP Analysis vs. Internal Audit: Selecting the Best Approach
Nadia Ragnvald Caspersen Senior consultant, Medical Device QA – GBA Key2Compliance In the high-stakes world of medical devices, where patient safety and regulatory compliance are non-negotiable, understanding the nuances between GAP analysis and internal audits can be a game-changer. While both are valuable tools for enhancing performance and ensuring regulatory adherence, they serve distinct purposes […]