ISO 13485 Guidelines: 8 Steps to Securing ISO 13485 Certification
Medical device manufacturers, suppliers, and service providers need to have a clear understanding of ISO 13485 guidelines. ISO 13485 is the internationally recognized standard for quality management systems (QMS) for the medical device industry. In this blog, we have...
ISO 13485 Design Changes: Device Design Change Control
Design changes in medical devices could be modifications made to the design, materials, functionality, or intended use of the device. Moreover, changes in medical device design, manufacturing processes, or regulatory requirements are inevitable in the industry. Hence,...
Common ISO 13485 Audit Mistakes You Can Avoid: 5 Easy Steps
In this blog, we have curated a detailed step-by-step guide to help you avoid the common ISO 13485 audit mistakes. Additionally, we have highlighted why should you bother with ISO 13485 certification and how to secure it. What is ISO 13485? ISO 13485 provides...