PCE specialist micrometal awarded ISO 13485 certification
micrometal, a specialist in developing photo chemical etching (PCE), has again been awarded ISO 13485 accreditation.
micrometal’s years working in the medical device sector has demonstrated the need for precision metal parts and components due to the nature of these devices. Even the slightest imperfections can lead to malfunctions, compromised patient safety, and regulatory non-compliance.
micrometal’s PCE process allows the production of detailed and complex parts with minimal material stress, preserving the integrity of the metal and eliminating the risk of burrs or distortions. Additionally, the process offers exceptional repeatability and tight tolerances, guaranteeing consistent quality across large-scale production. This makes PCE exceptionally well-suited for crafting intricate, burr-free, and dimensionally accurate parts that adhere to the stringent requirements of the medical device sector.
Jochen Kern, head of sales and marketing at micrometal said: “ISO 13485 accreditation is of paramount importance for a subcontract precision metal part manufacturer like micrometal, as it signifies our compliance with rigorous quality management standards specific to the medical device industry. This accreditation demonstrates our commitment to producing components via our next generation PCE process that adhere to the highest levels of quality, safety, and traceability, critical for medical devices where precision, reliability, and consistency is non-negotiable. ISO 13485 not only enhances our credibility and marketability within the healthcare sector, but also ensures seamless collaboration with medical device companies by aligning their processes with industry best practices, ultimately contributing to the delivery of safe and effective medical products.
“From our perspective at micrometal, ISO 13485 certification underscores a profound dedication to the medical device sector and signifies a superior level of service. By meeting the stringent requirements of this industry-specific quality management standard, we have demonstrated our unwavering commitment to delivering products and services of the highest quality, precision, and reliability. ISO 13485 not only ensures compliance with rigorous regulatory standards but also showcases a proactive approach to risk management, process optimization, and continuous improvement. This commitment enhances trust among medical device manufacturers and end-users, affirming our capability to contribute to the development and production of safe and effective medical devices, thereby solidifying our position as a valued partner in the healthcare ecosystem.”