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.
