SCHURTER Elevates Medical Device Standards with ISO 13485 Compliance

Santa Rosa, California, April 10th, 2024 - SCHURTER, a leader in innovative technology solutions, underscores the pivotal role of adhering to stringent standards in medical device development. In this recent Application Note, SCHURTER emphasizes the importance of compliance with the medical standard DIN EN ISO 13485 to ensure the safety and reliability of medical equipment, specifically as it relates to the development and integration of HMI solutions.

Certification under DIN EN ISO 13485, coupled with meticulous component selection and innovative design methodologies, enables manufacturers to achieve superior product quality and process reliability. Key aspects of the standard include well documented processes and procedures, risk management, change management, supplier management, validation and verification of processes, traceability, and training and competence. By attaining the certification, along with adept component integration and innovative design techniques, SCHURTER paves the way for the development of top-tier Human Machine Interface (HMI) solutions tailored specifically for medical applications. Examples of applications include surgical and intensive care medicine, diagnostics, laboratory, dental, physiotherapy, and medical home care.

SCHURTER offers an extensive portfolio of certified and safe products under DIN EN ISO 13485, providing support to its customers throughout the entire product lifecycle. This includes navigating regulatory compliance complexities, such as those concerning the Medical Device Regulation (MDR) and FDA (Food and Drug Administration) requirements.

Read more about the importance of the medical standard for medical devices in the full Application Note Link to Application Note. For sales and product information, contact SCHURTER at (800) 848-2600 or by email at [email protected].

About SCHURTER Inc

The SCHURTER Group is the world's leading Swiss technology company providing components that ensure safe power supply and simplified equipment operation. The company’s professional competence, innovative strength, and distinctive corporate culture, propel the SCHURTER Group, together with its customers and partners, into the digital future. The safe&easy brand claim not only refers to the products, but also the company’s business philosophy, which strives for sustainable success through innovation, high-quality products and service, flexibility, and proximity to customers.

SCHURTER is known globally as an innovator, manufacturer and distributor of fuses, connectors, circuit breakers, switches, and EMC products. SCHURTER products and solutions are developed especially for specific industry segments – medical, data and communication, automotive, avionics & space, energy, and the broader industrial market. SCHURTER considers the quality of its products and services as the key factor to the company's lasting success. Its management and improvement processes are designed and certified according to ISO 9001, ISO 13485, ISO 14001, ISO 45001 and IATF 16949, using the EFQM and Baldrige Excellence Models, as well as the application of Lean Management principles such as Value Stream Planning, Power Innovation, SSO, and Six Sigma.

SCHURTER Inc, Santa Rosa, California is the exclusive North America sales and distribution office for the SCHURTER Group.

Editorial Contact: Myra Hallman
[email protected]

- Read less