Benetech Inc. announces receipt of ISO 13485:2016 Certification

December 21, 2020

Toronto, Canada.  (December 21, 2020) Benetech Inc. is a software development company that creates and markets tools for use in prenatal screening.  Its flagship product, Benetech PRA is used daily by hundreds of leading hospitals and labs around the world to screen millions of pregnancies each year for congenital anomalies.

Benetech is pleased to announce that it has received notice from UL LLC® that it has completed its assessment of Benetech’s quality systems and found it in compliance with the guidelines for ISO 13485:2016.

“This marks an important day for our company”, said company president Les Hansen, “ISO standards are the highest in the world and we are proud to be certified by them.”

The certification applies to the design and development, manufacture and servicing of software used for calculating the risk of prenatal anomalies.


Les Hansen
Benetech Inc.
1 800 253 8611


About Benetech Inc.

Located in Toronto Canada, Benetech was founded in 1987 and has been privately owned and operated ever since.  Benetech PRA is used by some of the leading hospitals and labs in the world and is considered a gold standard for prenatal screening.  The quality systems of Benetech Inc. have been registered by UL LLC.® to ISO 13485:2003.  More information on Benetech Inc. and its products can be found at

About UL

UL LLC.® is a premier global independent safety science company with more than 118 years of history.  Employing more than 10,000 professionals in over 100 countries, UL has five distinct business units – Product Safety, Environment, Life & Health, Knowledge Services, and Verification Services – to meet the expanding needs of our customers and to deliver on our public safety mission.  Additional information about UL may be found at

By |December 21st, 2020|Categories: News, PRA, Press Release|0 Comments