Menu

Regulatory Documentation

Richardson Healthcare is dedicated to providing products and services of the highest quality, performance, and reliability.

ISO 13485:2016

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.

ISO 13485 Press Release

MDSAP Certification

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.

MDSAP 743094 Certificate

Canada Device License

Richardson received the Canada Device License for the ALTA750 (RELL43001035) on May 18, 2022. License number: 107770

Canada Device License 

CE 697580 Certificate

Richardson Electronics received the EC Certificate – Full Quality Assurance System, No. CE 697580

CE 697580 Certificate

FDA Registration

Richardson Electronics’ FDA registration number is 1120044 and can be verified by visiting the fda.gov website.




ISO 13485:2016 Certificate

MDSAP

Canada Device License

CE Certification

Our website uses cookies. By continuing to use this website you agree to our use of these cookies. For more information on our cookie use, see our privacy policy.

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.

Close