Pelstar LLC, the maker of Health o meter® Professional scales, is a certified ISO 13485:2016 and ISO 9001:2015 company. These certifications mean that we manage our company at the standards of the International Organization for Standardization (ISO). ISO 13485:2016 sets forth requirements for the management system of design and manufacture of medical devices, such as meeting regulatory and customer requirements while also managing risk and efficiency. ISO 9001:2015 are the standards used to manage our quality management system, ensuring the company consistently provides products and services that meet customer and regulatory requirements and demonstrates continuous improvement.
Some of our products have been tested for additional certifications, such as CSA/cMet and Class III. Refer to a product’s Features and Benefits sheet to learn about specific certifications.
All of our products are registered with the US Food and Drug Administration as Class I medical devices.
Refer to a scale’s product page to learn about specific certifications.