At CPUSYS, we excel in developing customized software solutions precisely tailored to our clients’ specifications. Our proficiency lies in crafting FB or FC software modules that precisely align with our clients’ designs. We take pride in our ability to deliver functions that meet industry-standard software guidelines, including IEC 62304 with IEC 61010-1, ISO/IEC 12207, ISO 13485:2003, and more. This commitment ensures that our products not only meet but exceed the highest quality standards while also adhering to market safety requirements. With CPUSYS, you can trust that your software needs are in capable hands, delivering excellence every step of the way.
- IEC 62304: This standard specifies lifecycle requirements for the development of medical software and software within medical devices. It outlines processes such as software development, maintenance, risk management, and configuration management to ensure the safety and effectiveness of medical software.
- IEC 61010-1: This standard outlines general safety requirements for electrical equipment used for measurement, control, and laboratory use. It covers aspects such as electrical safety, mechanical safety, and environmental testing to ensure the safe operation of such equipment.
- ISO/IEC 12207: This standard provides guidelines for software lifecycle processes, including software development, maintenance, and configuration management. It aims to standardize processes to improve the quality and efficiency of software development projects.
- ISO 13485:2003: This standard specifies requirements for a quality management system for medical device manufacturers. It covers aspects such as design control, risk management, production processes, and regulatory compliance to ensure the safety and efficacy of medical devices.
These standards play a crucial role in various industries, particularly in ensuring the safety, quality, and effectiveness of software and equipment used in healthcare, industrial control, and other critical sectors. Compliance with these standards is often required by regulatory bodies and is essential for maintaining the trust and confidence of customers and stakeholders.
