Irdeto has successfully demonstrated its capacity to deliver cybersecurity solutions that guarantee the security of medical devices throughout their lifecycle and market placement.
Irdeto, the world leader in digital platform cybersecurity is pleased to announce that it 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 the development, implementation, and maintenance of management systems for the medical device industry around the world.
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 consistently deliver in accordance with customer expectations and relevant regulatory mandates. This encompasses various aspects such as design, development and placing on the market of cybersecurity software 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, instills in our clients the confidence and assurance they expect from top-tier quality manufacturing and delivery. It further reiterates for our customers that Irdeto is capable of delivering a portfolio of security technologies that aligns seamlessly with regulatory and management system requirements, while providing them with reports for their own 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.”
Irdeto dedicated 14 months and significant resources to achieve ISO 13485 certification, fostering trust with customers and strategic partners in the MedTech sector. This accomplishment attests to the excellence of Irdeto’s solutions, demonstrating its ability to guarantee the security of medical devices throughout their lifecycle and market placement.
Irdeto’s other ISO Quality Assurance certifications include:
ISO 9001 – Quality Management System Certification
ISO 27001 – Information Security Management System Certification