ISO 13485 Archives

ISO 13485 Design Changes: Device Design Change Control

by Sudhriti M | Apr 8, 2025 | Medical Device

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

by Sudhriti M | Feb 16, 2025 | Medical Device

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...

4 Key Steps for Effective Internal Audit of ISO 13485:2016 QMS

by Sudhriti M | Feb 4, 2025 | Medical Device

QMS helps ensure medical devices being manufactured are consistently meeting strict quality standards, thereby ensuring their safety and efficacy. A robust QMS helps medical device manufacturers reduce errors, minimize risks, and ensure product quality. The ISO...

ISO 13485 Design Changes: Device Design Change Control

Common ISO 13485 Audit Mistakes You Can Avoid: 5 Easy Steps

4 Key Steps for Effective Internal Audit of ISO 13485:2016 QMS

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