Initial Consultation
We begin by understanding your business needs and recommending the most suitable certification(s).
About ISO 13485:2016 Certification
ISO 13485 is a globally recognized standard that outlines quality management system requirements tailored specifically for the medical device industry. It ensures organizations meet regulatory demands, including the U.S. FDA’s Quality System Regulation (QSR), covering critical areas like documentation, labeling, and complaint handling.
Aligned with ISO 9001 principles, ISO 13485 offers a robust framework for the design, development, and manufacturing of medical devices, ensuring consistent quality and patient safety.
Our certification services are streamlined, affordable, and fully supported—from documentation to tender eligibility. With international validity, ISO 13485 certification enhances trust and market access across global healthcare sectors.
