22 08, 2012

Benetech Inc. announces receipt of CE Mark for Benetech PRA

By |August 22nd, 2012|Categories: News, PRA, Press Release|0 Comments

August 22, 2012

Toronto, Canada.  (August 22, 2012) 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 chromosomal anomalies.

Benetech announced today that it has received CE Mark approval for its Benetech PRA software product for prenatal screening.  Full information on the certificate is as follows:

EC Certificate – Full Quality Assurance System Approval Certificate
Annex IV, section 3 of Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices

Scope

2 08, 2012

Benetech Inc. announces receipt of ISO 13485:2003 Certification

By |August 2nd, 2012|Categories: News, PRA, Press Release|0 Comments

August 2, 2012

Toronto, Canada.  (August 2, 2012) 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 chromosomal anomalies.

Benetech announced today 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 13485:2003.

“This marks an important day for our company”, said company founder Ken McEvoy, “ISO standards are the highest