Honeywell's Spectra Medical Grade (MG) fibre has received ISO 13485 certification for manufacturing to supply the medical device industry.
ISO 13485, the highest management standard for the medical device industry, specifies requirements for a quality management system (QMS) where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Spectra MG, an ultra-lightweight and ultra-high strength fibre, is incorporated into the design of medical devices used in minimally invasive procedures. It gives medical device manufacturers greater flexibility to design and build smaller, stronger and lighter devices.
The ISO 13485 certification will allow Honeywell to implement a medical device QMS to identify, manage and minimise the risks involved with the manufacturing and sale of raw materials and components for medical devices. The certification will improve processes and ensure quality consistency by defining requirements and standards that meet medical device industry requirements.
“As regulations become more stringent, this certification is critical for our customers and will help them manage their risk and help enable regulatory approval of their devices,” said Abey Paul, business leader for Spectra MG Fiber, at Honeywell. “With Spectra MG, medical device manufacturers can continue to develop and bring to market smaller and more effective devices that are stronger and lighter in weight.”
The certification will also enable cost reductions of non-conforming products for customers, and help them meet the objective standard of excellence to enhance their competitive advantage in the marketplace.
Compared with conventional polyethylene fibre, Spectra MG has an ultra-high molecular weight, high degree of orientation, and crystallinity, that leads to higher fibre strength and better wear resistance to surface damage. It is three times stronger than polyester in a volume basis and is highly resistant to chemicals, water and ultraviolet light. Spectra MG fibre’s high resistance to chemicals, fatigue and abrasion and low friction for easier movement, makes it a suitable biomaterial for many applications in the medical device industry.