Richardson Healthcare is dedicated to providing products and services of the highest quality, performance, and reliability.
In 2018, Richardson Electronics was awarded ISO 13485:2016 certification. This certification validates the consistent design, development, production, and delivery of medical devices that are safe for their intended purpose. To be certified, Richardson Healthcare demonstrated the ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
With this certification, customers can be confident that Richardson is dedicated to maintaining the highest level of quality, efficiency, and responsiveness.
In 2021, Richardson Electronics was awarded MDSAP Certification.
The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. To be certified, Richardson Electronics demonstrated the ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
Richardson received the Canada Device License for the ALTA750 (RELL43001035) on May 18, 2022. License number: 107770
Richardson received the Canada Device License for the ALTA750G on January 25, 2023. License number: 108809
Richardson Electronics received the EC Certificate – Full Quality Assurance System, No. CE 697580
Richardson Electronics’ FDA registration number is 1120044 and can be verified by visiting the fda.gov website.
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