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ISO 13485 Certification | My ISO Consultants
SO 13485 is an internationally recognized standard that outlines the requirements for a quality management system specific to the medical devices industry. It ensures that organizations consistently design, develop, produce, and deliver medical devices that meet both customer and regulatory requirements. Essentially, ISO 13485 provides a framework for managing the quality of medical devices throughout their lifecycle.
My ISO Jay
May 24 min read
The Importance of Outsourcing ISO and AS9100 Internal Audits to Qualified Experienced Auditing Firms | My ISO Consultants
Outsource ISO and AS9100 audits to My ISO Consultants for expert, unbiased insights, efficient processes, and continuous improvement.
My ISO Jay
Jan 162 min read
FDA's Transition from FDA 21 CFR Part 820 to ISO 13485: What It Means for Medical Device Manufacturers | My ISO Consultants
FDA to adopt ISO 13485 in Feb 2026, aligning U.S. medical device regulations with global standards for improved quality and market access.
My ISO Jay
Dec 18, 20243 min read
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