Precision Micro, Europe’s market-leading supplier of photo-etched components, announces that it’s now certified to ISO 13485 — the internationally recognised quality management system for medical device manufacturers. The accreditation was awarded following a successful site audit conducted by the British Standards Institution (BSI), the national standards body of the United Kingdom.
Precision Micro commands a unique position in the area of photo etching through an unprecedented level of competency which is built upon an over 50-year pedigree in the sector, and an absolute focus on precision that enables the company to accurately, reliably, and above all repeatedly create components that make a positive difference to a wide range of high-tech engineering applications.
The company continually seeks to invest in the photo etching process for the benefit of its customers, and with an increasing number of customers coming from the medical device sector, the attainment of ISO 13485 shows its commitment to this important growth market.
“Precision Micro has focused on obtaining the relevant quality management system for each of the core high-value engineering markets it supplies,” said Carl Smith, Precision Micro’s quality manager. “Having already secured AS 9100 (aerospace) and IATF 16949 (automotive), securing ISO 13485 was the next step and shows our commitment to not only meet, but exceed the needs of a growing medical customer base. We are extremely proud to have attained this stringent and prestigious standard in less than 12-months.”
ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
Companies with ISO 13485 certification communicate a commitment to quality to both customers and regulators, and it is a tangible demonstration of the fact that Precision Micro is able to produce components for safe and effective medical devices that meet the regulatory requirements of its customers. Precision Micro is one of a small number of photo etching companies to hold ISO 13485, and the only accredited European etching supplier to the medical device sector.
Photo etching is a highly precise, tightly controlled corrosion process used to produce complex, burr- and stress-free metal components with very fine detail. It is well suited to the manufacture of parts from medical grade metals and alloys characterised by their high strength-to-weight ratio, biocompatibility and corrosion resistance.
Since a €1,000,000 investment in its titanium etching capability in 2015, the company has seen a surge in demand for medical implants, including craniomaxillofacial meshes and components used in pacemaker batteries. Precision Micro uses its 50-plus years of expertise to constantly refine the processes and etchants necessary to machine exacting materials such as titanium, and because of this, the company is able to offer scalable production of highly precise photo-etched titanium medical devices.