Medifab, a leading New Zealand headquartered medical device company, has announced the deployment of Promapp’s cloud-based business process management software to support the company’s global expansion as well as compliance with the US Food and Drug Administration and international quality standards.
Medifab’s products make a positive difference to the lives of persons with a disability through the provision of leading edge postural support solutions for a wide range of special needs. It offers more than 130 products which include everything from wheelchairs, standing aids, beds and bathroom aids through to strollers and push chairs, indoor seating, car seats and harnesses.
Operating in a highly regulated industry, the company must comply with significant quality systems and regulatory requirements to meet its customers’ needs. These requirements are intended to ensure that Medifab consistently designs, produces and markets medical devices that are safe and effective for their intended purpose. Indeed, the latest revisions in global quality standards and regulations has meant an increased emphasis and focus at Medifab to identify and manage its product and business risks.
In recent years the company’s manufacturing and operations centre has been certified to the ISO 9001 Quality System and ISO 14001 Environment Management standard. However, Medifab’s growth and business plans to export to overseas markets requires compliance with specific Medical Device regulations, in particular ISO 13485 (Medial Devices Quality management systems – Requirements for regulatory purposes) and the USA FDA’s Current Good Manufacturing Practice (CGMP) regulations, 21 CFR 820.
These regulations govern the methods and controls Medifab uses to design, manufacture, package, label, store, distribute and service its products.
Finding the Right Solution
Medifab went to market for a solution which would support the organisation’s ability to meet the requirements of the global market. A business process management tool would also support the creation of the right culture and structure to support the transition of the business from a service-based company to a global manufacturer.
Innovation and product development would in turn need the support of sophisticated processes which could be easily understood and maintained by everyone in the business.
More than 300 Process Improvements Underway in Six Months
Since seamlessly launching Promapp throughout the business in September last year, Medifab has published 42 processes and actioned over 300 improvements. This has significantly raised the level of collaboration among different teams and helped the company to improve performance to meet customers’ expectations while setting it up to start the formal ISO 13485 certification process.
While Medifab currently uses ISO 14971 (Medical devices — Application of risk management to medical devices) as a key component in its business and product development processes, Promapp’s Risk Management module and associated workflow makes this requirement straightforward to manage and administer.
Medifab is also using Promapp’s Improvement module to record and manage customer feedback, complaints, internal non-conformances, engineering change requests and opportunities for improvement. Promapp’s built in workflow allows users to easily manage and monitor the timely closure of these opportunities and incidents.
In addition, being a web based system means that Promapp is accessible from any device in any location. It can also integrate with other systems which makes the investment in processes sustainable. At the same time, sharing processes through their ERP and CRM systems promotes higher frequency viewing of processes.