The compliance technology helps bring all employees together on the same pages.

SAN FRANCISCO (March 27, 2017)—Medifab, a medical device company, has announced it will deploy Promapp’s cloud-based business process management software to support the company’s global expansion and comply with U.S. Food and Drug Administration (FDA) and international quality standards.

Medifab offers more than 130 products—including pediatric, adolescent and adult wheelchairs, standing aids, bed and bathroom aids, strollers and push chairs, indoor seating, car seats and harnesses—all of which make a positive difference in the lives of persons with disabilities by providing postural support solutions for a wide range of special needs.

“Because we’re expanding internationally with our complex seating products, storing processes and standard operating procedures in static formats such as Excel and Word was increasingly holding the business back from its full potential,” says Stuart Clook, quality and regulatory affairs manager at Medifab. “These processes were not only difficult to manage, but also became outdated easily and were often misunderstood by staff.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.”

Clook notes that Medifab looked at several solutions before concluding that Promapp offered more than just a compliance and risk tool. “Promapp could also be our core solution for ongoing business process improvement,” he explains. “Having compared Promapp’s feature functionality against our existing programs, it was easy to see that our staff would be able to easily create, maintain and share processes, enabling us to reduce costs while meeting our commitments and responsibilities to customers and regulators worldwide.”

Because it operates in a highly regulated industry, Medifab must comply with significant quality systems and regulatory requirements, which ensure the company consistently designs, produces and markets medical devices that are safe and effective for their intended purpose.

In recent years, Medifab’s manufacturing and operations center has been certified to the ISO 9001 Quality System and ISO 14001 Environment Management standard. Its plans to export to overseas markets, however, require compliance with specific medical device regulations governing the methods and controls used by Medifab to design, manufacture, package, label, store, distribute and service its products.

Since launching Promapp in September 2016, Medifab has published 42 processes and implemented more than 300 improvements. “This has significantly raised the level of collaboration among different teams and helped the company to improve performance to meet customers’ expectations,” says Clook.

 “While our mission is to make a positive difference in the lives of persons with disabilities, therapists, and caretakers, Promapp has also made a positive difference to our staff,” Clook continues. “It has been readily embraced by our 60 employees and has smoothed the path for growth across all operations. It's a perfect vehicle for continuous improvement and capturing new and updated processes on an ongoing basis.”

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