New Zealand based medical devices company Medifab is to deploy Promapp’s cloud-based business process management software to support compliance with the US Food and Drug Administration and international quality standards as it expands its international operations.
Medifab manufactures some 130 products to assist people with disabilities. These include wheelchairs, standing aids, beds and bathroom aids, strollers, push chairs, indoor seating, car seats and harnesses. Many of its products are governed by regulations designed to ensure their safety and effectiveness.
In particular its export plans require compliance with 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 govern the methods and controls Medifab uses to design, manufacture, package, label, store, distribute and service its products.
Medifab’s quality and regulatory affairs manager, Stuart Cook, said the company’s previous practices of storing processes and standard operating procedures in various static formats such as Excel and Word was increasingly holding the business back from its full potential. “Not only were these processes difficult to manage but they also fell out of date easily and were often misunderstood by staff.
“At the end of the day, there is little value in a procedures manual that nobody looks at or updates.In order to future proof and facilitate our future business growth, we knew that all our staff had to be on the same page operating and managing processes that are simple and easy to understand.”
After reviewing several solutions, Clook said Medifab had concluded that Promapp could meet it basic compliance and risk management needs and also form the basis for ongoing business process improvement. “Having compared its feature functionality against our existing programs, it was easy to see that our staff would be able to easily create, maintain and share processes,” he said.
“Importantly, we would be able to reduce costs in some parts of the business while meeting our commitments and responsibilities to our customers and regulators worldwide.”
Medifab implemented Promapp in September 2016 and says it has since published 42 processes and actioned over 300 improvements using the system. “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,” the company said.
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.