Irdeto has earned the prestigious ISO 13485 certification from KIWA, a global specialist in Testing, Inspection, Certification (TIC) and Training. This internationally recognized and highly sought-after certification demonstrates Irdeto’s unwavering commitment to quality and cybersecurity in the medical device industry. The ISO 13485 certification, which focuses on quality management systems for manufacturers of medical devices, further underscores Irdeto’s dedication to meeting and exceeding the highest industry standards.
The international standard ISO 13485 certifies the quality of management systems in companies which manufacture or distribute medical devices or are part of the supply chain. ISO 13485 addresses the critical requirements that medical device manufacturers and suppliers must meet in developing, implementing, and maintaining management systems for the medical device industry worldwide.
Achieving this certification confirms that Irdeto has not only fulfilled all the prerequisites for a robust quality management system but has also showcased its capability to deliver following customer expectations and relevant regulatory mandates consistently. This encompasses various aspects such as design, development and placing on the cybersecurity software market for medical devices and providing cybersecurity services for medical devices.
Niels Haverkorn, Senior Vice President and General Manager for Connected Health at Irdeto, highlighted the significance of this accomplishment, “This ISO certification, complemented by the array of other ISO and independent third-party certifications which we have received, instils in our clients the confidence and assurance they expect from top-tier quality manufacturing and delivery. It further reiterates for our customers that Irdeto can deliver a portfolio of security technologies that aligns seamlessly with regulatory and management system requirements while providing them with reports for their conformity assessment systems.”
Andrea Biasiucci, CEO of confinis ag, commended Irdeto’s achievement, stating, “As a company that has ensured regulatory compliance in the MedTech arena for nearly two decades, we value partnerships with organizations that embrace industry-leading standards. The ISO 13485 certification is a very significant milestone. Irdeto’s investment to achieve it showcases their commitment to ensuring the highest level of quality and cybersecurity for medical devices, contributing to the overall trustworthiness of the industry.”