"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.
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, we accelerate value creation for our clients in R&D, Manufacturing & Supply Chain, Marketing, Sales & Services, to ultimately benefit patients.
Our solutions and services include Digitalisation, Data, IT & Infrastructure; Product Lifecycle Management; Industry Compliance & Managed Services and People & Culture. As an independent solutions and Managed Service provider, we have the flexibility to prioritise our clients’ best interests without being constrained by exclusive partnerships. We follow an outcomes-based approach – from strategy to hands-on delivery and beyond.
With a well-established reputation built over two decades, we have earned the trust of leading companies in Pharma, MedTech, Healthcare and Start-ups. Headquartered in Switzerland, we employ more than 250 specialists and professionals, with offices in North America, Europe and APAC.
We make healthcare better, globally!
Arcondis Holding AG
Hegenheimermattweg 167b
CH4123 Allschwil BL
Telefon: +41 (61) 71782-00
Telefax: +41 (61) 71782-01
http://www.arcondis.com/
Global Communications Manager
E-Mail: comms@arcondis.com
Global Marketing & Campaigns Manager
E-Mail: Rita.Pienaar@arcondis.com
