Ferra Engineering has announces its accreditation with the ISO:13485 medical manufacturing standard by TUV Rheinland.

Ferra Engineering has increased its medical manufacturing credentials by achieving the international standard for good manufacturing practice, ISO: 13485. Ferra Engineering’s new accreditation reinforces the company’s commitment to providing high quality component manufacturing services to the Australian medical device manufacturing industry.

Mark Scherrer, CEO of Ferra Engineering said, “Achieving ISO:13485, coupled with our expertise in titanium machining, and backed up by our team of expert manufacturing engineers, means we can offer the Australian medical manufacturing industry a quality local solution for the manufacture of components and assemblies.” Mark went further to say, “We also have absolute control over every process in our factory from sales to production, right down to individual component serial number tracking through our advanced SAP management system.”

Ferra Engineering is one of the largest CNC machining companies in Australia and can offer a range of medical manufacturing services including prototype manufacturing, short run manufacturing, high volume production, Materials Requirement Planning (MRP), Bill of Materials (BOM) control, component sourcing, final assembly of mechanical and electro-mechanical devices, packaging and product validation services. Ferra Engineering’s global supply expertise makes it the manufacturer of choice for any medical device manufacturer exporting to global markets.

As a result of achieving ISO:13485 Ferra Engineering is already working on a number of large medical manufacturing projects involving titanium machining for implantable devices and the complete manufacture, packaging and distribution of an innovative electro-mechanical device being exported to Europe, and eventually the USA. “We have been particularly successful in helping some of the larger medical manufacturing companies in Australia to move from using their small, local machine shop for small runs to manufacturing quality components in volume as their sales grow rapidly,” Mark said.

ManufactureLink, the Australian custom manufacturing and engineering network, has been instrumental in Ferra Engineering gaining new customers in the Australian medical devices industry. “We chose to promote our company’s capabilities on the ManufactureLink network after we learned that the medical devices industry is one of their biggest users,” Mark said. “After registering as a supplier, and creating a profile on the directory, it wasn’t long before we were contacted by a number of potential customers enquiring about our capabilities.”

Consequently, Ferra Engingeering won work with companies like Ventracor, the Australian manufacturers of artificial hearts. Mark said, “Ventracor visited us in Brisbane and conducted a thorough audit of our process control systems. They wanted us to demonstrate on the spot how we control information and production as jobs moved through our factory. I’m happy to say we passed with flying colours, which speaks volumes about the quality of the systems we have put in place.”

George Pofandt, Managing Director of ManufactureLink said, “When companies like Ferra Engineering choose to gain their ISO:13485 accreditation, this provides a fantastic boost to the local medical device manufacturing industry, and we hope to see more manufacturers undertake to gain their accreditation. Almost every medical device manufacturer in Australia intends to sell their products to global markets. Using suppliers accredited with having good manufacturing practice makes it easier for them to get their devices approved for sale in markets like the USA.”

Australian manufacturers gaining accreditation also helps to keep work onshore. “So often we see medical device manufacturers eventually taking their production offshore, due to a lack of local expertise, lack of companies with suitable accreditations, lack of tight process controls, lack of understanding of medical manufacturing issues, or simply a lack of capacity to manufacture quality components in volume at a globally competitive price,” George said.  “Medical devices offer unique manufacturing challenges so we also see many local manufacturers who are just not willing to spend the money on R&D to develop innovative manufacturing solutions.”

With more and more innovative Australian companies developing new medical device products for the global market, manufacturers like Ferra Engineering and other medical device manufacturers will play an important role in establishing Australia as a key producer of the world’s medical devices. As devices become smaller and smaller, manufacturers who develop expertise in micro-manufacturing and nanotechnology will also play in increasingly critical role in preventing Australian manufacturing heading offshore.

“I hope to see Australia become one of the world’s leading manufacturing hot-spots for medical devices as more local suppliers take up the challenge,” said George, “The culture of innovation and entrepreneurship seems to be here; we just need the manufacturing expertise to support it. We also need the local manufacturers to understand that taking a new device to market can be a long process and they need to make a large investment of time and resources over a long period before they will see a return in production orders.”

However, if the example set by Ferra Engineering is anything to go by, the future looks bright for the local medical devices industry.

Contact Ferra Engineering

To learn more about Ferra Engineering's capabilities or to contact them, click here to visit their supplier showroom on ManufactureLink.

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