Rutland Plastics has attained the medical standard ISO13485. Building on its ISO9001 accreditation, the company now has additional approval for the manufacture of non-sterile injection and flow moulded thermoplastic components for medical devices and the machining, finishing and sub-assembly of mouldings to customers’ requirement.
Of particular importance in this standard are risk management and maintaining effective processes specific to the safe manufacture of medical devices, explains the company.
A number of products are already manufactured by Rutland Plastics for the medical sector, and achieving this standard demonstrates proven business credentials through independent verification. This is the culmination of many months hard work led by QC Inspector Lee Hatton.
“This is a growing market for plastic mouldings due to the high usage of disposables,” commented Rutland Plastics’ managing director, Steve Ayre. “Medical is a market we would like to develop further. This standard not only demonstrates our commitment but also the level of service we can provide due to our focus on maintaining a clean mouldshop backed up by effective quality assurance processes.”
In addition to injection moulding Rutland Plastics offers design and tool-making to machining and assembly services, including sonic welding and gluing as well as being specialists in gas assisted moulding. It is also able to offer rapid prototyping in multiple materials using its Objet Connex 350 3D printer, either in conjunction with prospective moulding work or as a standalone service.
