With a mission to bring comfort and functionality to people living with complex rehabilitation needs, Canterbury-based company Medifab, who design, manufacture and export specialist seating and disability equipment, have achieved ISO 13485:2016 certification – the internationally recognised standard that guides medical device manufacturers in implementing quality management systems to achieve industry distinction.
Trusted and recognised by regulatory authorities across the world, ISO 13485 demonstrates a commitment and excellence to producing medical devices that meet rigorous safety, quality and efficacy standards: a certificate that most major markets require from medical manufacturers looking to sell products in their country.
“We’re thrilled to attain the ISO 13485 certification,” explains Medifab’s Managing Director, Roger Mascull.
“Now Medifab is globally compliant to the highest applicable industry standard, we can advance our global aspirations. The certificate offers peace of mind for local government healthcare procurement and gives us the licence to operate internationally.”
The disciplines involved in attaining and maintaining this prized certification outcome has elevated Medifab’s processes, systems and procedures, which Roger says will continue to enhance the company’s developments.
“We’re always committed to improving our products and processes. And now we have this certification, we can continue to shape better lives on a global scale. This is a huge achievement and is a credit to the dedication of everyone at Medifab.’”
With the addition of ISO 13485 to its impressive list of ISO 9001 and 14001 certifications, Medifab’s commitment to quality, service and the environment is reinforced and places it as one of the highest quality manufacturing facilities in the whole of New Zealand.
‘We’ve been working very hard for the past 12 months to earn this certification. The whole company, from the engineers and production teams through to the sales and logistics teams, have demonstrated great collaboration and determination to achieve this certification on our first application’ says Stuart Clook, Medifab’s Quality and Regulatory Manager.
Grown from small beginnings, Medifab’s story has been driven by a single-minded purpose – to bring comfort and functionality to people living with disabilities.
Established in 1990 and built from the ground up by a Kiwi family, the company’s innovation and success comes down to their genuine desire to help people living with disabilities.
Working closely with therapists, carers and clients, their customer-focussed approach and ‘whatever it takes’ attitude has enabled them to provide break-through technologies that shape better lives every day.