IEC 60601-1 Certification Consulting

Achieve Certification and Safe & Reliable Performance with IEC 60601 Expertise

Overview:
 

Placing a safe and reliable medical device in the hands of healthcare professionals is critical. At Noblitt & Rueland, we are your one-stop shop for navigating the complexities of IEC 60601, the international standard for electrical safety in medical devices.

Our team of electrical safety specialists possesses a wealth of experience in applying IEC 60601 requirements including EMC (-1-2), collateral (e.g. alarms, usability, home use, etc.) & particular standards (-2-X) throughout the entire development lifecycle. We offer comprehensive consulting services, including risk assessments, design reviews including isolation diagram review, test plan development, and support during testing and certification. From concept to market, we ensure your device adheres to the most rigorous safety standards.

Without compliance to the current editions the ability to sell in the U.S. and globally will be affected. Many products sold in the EU (new & current production) now need to comply with the latest IEC 60601 standards. To ensure readiness, devices currently being designed should comply. Now is the time to understand how your device is impacted including planning and scheduling for new testing or product modifications that may be required.

Don't compromise on patient safety. Partner with Noblitt & Rueland for expert IEC 60601 consulting to get your device certified. We empower you to develop medical devices that are not only innovative but also demonstrably safe and reliable, fostering trust with clinicians and patients alike.