PartnerTech, one of Europe’s leading contract manufacturing companies, announced today that its King’s Lynn manufacturing facility in Norfolk, England, has received ISO 13485:2003 medical certification. ISO 13485 is the international quality management standard for designers and manufacturers of medical devices. It is currently recognised in most major markets worldwide, including the European Union, United States, Canada, Japan, and Taiwan, and is a prerequisite for companies producing medical and biomedical products.
Gary Howse, managing director of PartnerTech’s UK operation, said: “This certification demonstrates our long term commitment to the UK medical device market, which is one of the world’s largest. It also builds on our ISO9001 and ISO14001 accreditations to reassure our customers that we have the quality systems in place to strictly control the manufacturing process, the traceability of components and materials used in medical products.”
PartnerTech has been designing and manufacturing medical and biomedical products for the past 15 years, and this market is one of the company’s key business segments and accounts for almost one fifth of total sales. Most of PartnerTech’s manufacturing facilities are now ISO13485-certified, which is of great benefit to multinational companies looking for a medical device development and manufacturing partner with both local presence and product lifecycle management.
PartnerTech has a wealth of experience in the medical market and offers the full range of services to medical product companies, including electro-mechanical capability, from product design, development, prototyping, new product introductions and test services, through to printed circuit board manufacture, system assembly and distribution. The King’s Lynn facility also boasts a 2000ft² class 10k clean room for manufacturing and assembling invasive medical products.
“Our ISO 13485 certification demonstrates that we have the processes in place to produce safe and effective medical devices,” added Julian Murphy, quality manager at PartnerTech’s King’s Lynn facility. “Our commitment to quality standards and to achieving operational excellence across the business ultimately enhances the profitability and competitiveness of our customers’ products by taking out cost, improving manufacturability and speeding time to market.”