Qualifying factories, suppliers, distributors and optics companies for ISO 13485 and preparing the technical files in accordance with SFDA regulations and medical products registration
In the ever-evolving world of healthcare, the innovation and integration of medical devices play a pivotal role in shaping the future of patient care. As manufacturers strive to bring cutting-edge solutions to the market, they find themselves entangled in the intricate web of regulatory frameworks. Among the myriad of guidelines, the juxtaposition of the Saudi […]
Difference Between SFDA & MDR Regulation Read More »
In the dynamic landscape of the medical device industry, ensuring quality and safety is paramount. One-way organizations achieve this is through ISO 13485 certification—a gold standard for quality management systems specific to medical devices. ISO 13485 is an international standard that specifies requirements for a quality management system (QMS) specifically tailored for the medical device
ISO 13485: Quality Management for Medical Devices Read More »
The medical field is an exceptionally sensitive domain, leaving no room for error; utmost attention to every detail is not merely an option but a mandatory requirement. Thus, implementing ISO 13485 quality management for medical devices is essential across all healthcare institutions. This article outlines the ISO 13485 quality management system for medical devices, its
ISO 13485 quality management system for medical devices Read More »
ISO 13485 standard holds significant importance for optics companies, suppliers, as well as distributors. Therefore, they strive to obtain it as much as possible, as this standard is among the global standards set by ISO for the quality management of medical devices and their regulation. If you are seeking this certification or looking for a
