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Brushless DC Motors Achieve ISO 13485 Certification

February 12, 2021

Brushless DC Motors Achieve ISO 13485 Certification for Respirators

 We’re excited to announce that our slotless brushless DC motors for respirators have recently received ISO 13485:2016 certification. Thanks to this compliance, medical device original equipment manufacturers (OEM) can be confident their motion control system has been manufactured to the highest quality standards.

Quality and Consistency—From Design to Distribution

Sourcing components with ISO 13485 certification is an important requirement for many medical device manufacturers. Expanding on ISO 9001, this standard contains specific requirements like parts traceability and risk management activities throughout the design and development stages. The standard also requires process and software validations at defined intervals.

Our ISO 13485 compliance is an important part of our quality management system and demonstrates our consistency in design, development, production, storage and distribution. As a result, OEMs can be certain that products manufactured at our 72,000-square-foot facility in Mumbai, India meet the highest standards for quality and consistency. The plant currently includes over 1,100 staff and is outfitted with machining, winding and injection moulding equipment, as well as an electrostatic discharge (ESD) safe assembly facility.

Brushless DC Motors Excel in Respirators

Our brushless DC motors are ideal for respirator applications due to their speed and precision. With a compact footprint as low as 13-millimeters in diameter, these motors feature nominal torque ratings between 1.7 and 275 milli-newton meters at speeds up to 90,000 revolutions per minute. And for respirator manufacturers, they provide smooth motion and low inertia for high acceleration. These motors also emit low noise and vibration and are highly efficient in battery-powered devices.

To learn more about our brushless DC motors, please visit our product page.