ISO 13485 Certification Awarded to Arcondis

Arcondis has achieved ISO 13485 certification.

“Achieving ISO 13485 certification is a significant milestone for Arcondis,” CEO Christian Hebich said. “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.”

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 product safety and efficacy.

“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,” Arcondis Global Quality Management head Patrick Zahnow stated.
 
Arcondis is a global professional services and consulting company exclusively focused on the life sciences and healthcare sector. Owned by a foundation and committed to healthcare improvement, the entity accelerates value creation for clients in R&D, manufacturing and supply chain, marketing, and sales and services. Arcondis’s solutions and services include digitalization, data, IT and infrastructure; product lifecycle management; industry compliance and managed services; and people and culture. As an independent solutions and managed services provider, Arconis follows an outcomes-based approach—from strategy to hands-on delivery and beyond. The company works with pharmaceutical, medtech, and healthcare clients as well as start-ups. Arcondis is headquartered in Switzerland, and employs more than 250 specialists and professionals in North America, Europe, and Asia Pacific.