Arcondis Achieves ISO 13485 Certification, Strengthening Commitment to Quality and Compliance

"Achieving ISO 13485 certification is a significant milestone for Arcondis," said Christian Hebich, Arcondis Chief Executive Officer.

“Not only does it reinforce Arcondis’ dedication to excellence but also positions us as a trusted partner for our clients who demand the highest standards in quality and safety.”

While ISO 13485 is traditionally associated with the medical device industry, its relevance is rapidly expanding into other sectors, including pharma. As the pharma industry becomes increasingly digitalised, the need for a quality management system like ISO 13485 is becoming more apparent.

Companies integrating managed services, health-related software and digital solutions into their operations must adhere to this standard to maintain high-quality management systems and ensure the safety and effectiveness of their products.

“ISO 13485 is essential because it ensures compliance with regulatory requirements, enhances safety, and improves global market access. As Arcondis rapidly expands its Managed Services offering, maintaining the highest level of quality is crucial to building trust with our clients,” adds   Patrick Zahnow, Global Quality Management Responsible at Arcondis.