Emergo has been acquired by UL (Underwriters Laboratories) as the consultancy expands its quality assurance and regulatory affairs service offerings.

Operating in 25 countries, Emergo has provided regulatory compliance resources and support for medical device and IVD manufacturers since 1997. For Emergo’s 2,800 clients worldwide, the acquisition will allow the consultancy to complement its global device registration, quality management, in-country representation and related services with UL’s depth and breadth of non-clinical testing expertise, which includes:

• Biocompatibility testing
• Microbiological and virological testing
• Cleaning, reprocessing and sterilization
• Software validation and verification
• Cybersecurity for medical devices

UL has provided safety testing and certification services across multiple industries since 1894. The company will retain Emergo’s name and global offices. The consultancy will operate as part of UL’s Health Sciences Division, and continue to be based in Austin, Texas.

By joining the UL group of companies, Emergo can offer clients more comprehensive support for medical device registration, QMS compliance and now, non-clinical testing and certification in order to get products to market faster.  Rene van de Zande, President and CEO of Emergo, says, “Medical device regulatory compliance involves keeping up with many moving parts, especially if you’re dealing with more than one market. Many small-to-mid size manufacturers simply lack the resources and expertise to navigate complex regulatory issues on a global basis.”  

“Both UL and Emergo share a common goal to positively impact medical device compliance and safety,” said Upayan Sengupta, Vice President and General Manager of UL’s Health Sciences business. “This acquisition provides us with an opportunity to provide medical device manufacturers with value added services as they introduce devices into new markets.”

You can read more about the acquisition in this press release.