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SCHURTER emphasizes how important it is for medical device developers to uphold strict standards.
In order to guarantee the safety and reliability of medical equipment, SCHURTER highlights in a recent Application Note how crucial it is to adhere to the medical standard DIN EN ISO 13485, particularly as it relates to the creation and integration of HMI solutions.
Manufacturers can attain improved product quality and process reliability by combining careful component selection with innovative design techniques with DIN EN ISO 13485 certification, highlighted the recently unveiled Application Note from SCHURTER.
Well-documented processes and procedures, risk management, change management, supplier management, process validation and verification, traceability, and competency and training are all important components of the medical standard DIN EN ISO 13485 and to create HMI solutions.
SCHURTER‘s accreditation, combined with skillful component integration and creative design methods, opens the door for the creation of superior HMI solutions made especially for the medical field. Surgical and intensive care medicine, diagnostics, laboratory, dentistry, physiotherapy, and medical home care are a few examples of applications.
With a broad range of safe and certified products including HMI scolutions under DIN EN ISO 13485, SCHURTER supports its clients in their entire product’s lifecycle.
This involves managing the complexity of regulatory compliance, such as those related to the FDA (Food and Drug Administration) and the Medical Device Regulation (MDR).
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