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 […]
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, […]
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 […]
Good Manufacturing Practice: Preparing for GMP Inspections and Addressing Common Challenges
Before going into the specifics of how pharmaceutical manufacturers can better navigate Good Manufacturing Practices (GMP) inspections, having a baseline understanding of GMP will help in properly preparing for inspections and avoiding common pitfalls. Simply put, GMP is a regulatory set of best practices that has been developed over time to ensure that products are […]
Meet Oscar He, our Senior Consultant and Coordinating Manager for internal audits!
Internal audits – an opportunity to improve medical devices Internal audits are an important activity for medical device manufacturers. They are 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. Oscar He is coordinating the […]