Medifab is a New Zealand-based medical devices company that manufactures and distributes more than 130 products to assist people with disabilities. These include wheelchairs, standing aids, beds and bathroom aids, strollers, pushchairs, indoor seating, car seats, and harnesses. They have staff headquartered in Christchurch, with satellite offices in Auckland, Sydney, and Tasmania.
ISO 13485 is critical for Medifab as it’s a quality management system (QMS) specifically for medical device manufacturers, so compliance with the regulatory requirements of the countries that they export to opens doors for Medifab. These requirements can be particularly challenging when dealing with certain parties, such as the FDA and European Union.
In this question and answer style webinar with Stuart Clook, Quality & Regulatory Affairs Manager at Medifab and Donna Outram, Promapp Account Executive they discuss how Medifab becomes ISO compliant, the challenges faced along the way and how they overcame these.
- How a standard approach drives visibility, efficiency and simplifies risk management
- How process management has streamlined the audit process
- How Medifab drive process engagement and audit trail accountability
Quality & Regulatory Affair’s Manager, Medifab