LaunchWorks today announced the opening of a new facility in the Montreal borough of Anjou to support the company’s continued growth and support in providing products to fight COVID-19. The new facility is registered with the FDA and received a Medical Device Establishment License (“MDEL”) from Health Canada.
The MDEL is a license issued to companies for the activities of manufacturing, importing and distributing (selling) of class I medical devices for human use in Canada. LaunchWorks Canada is operating with ISO 13485 compliance to achieve certification this year.
“We are very excited about our new facility and obtaining our MDEL and FDA registration. This is a key milestone in our plan to expand our products and services to the U.S. and Canada,” says Celine Barakat, General Manager of LaunchWorks. “And we look forward to applying our extensive manufacturing and service expertise to assist the Canadian molecular diagnostic market.”
“This new MDEL licensed facility reinforces our commitment to continue to expand and support the needs of the diagnostic industry in Canada and beyond,” added CEO of Integreon Global, Maurice Barakat. “Along with our investments in automation and device manufacturing the LaunchWorks service suite is uniquely positioned to meet the challenge of helping companies translate their science into commercial products.”
Originally formed within Enzymatics in 2009 in Beverly, MA, LaunchWorks has evolved over the past 12 years to become an ISO 13485 certified company that is FDA Registered. Integreon Global acquired LaunchWorks in 2017, and has since worked to add new service offerings, including a filling automation program designed to help its customers be more competitive. A significant portion of the company’s recent efforts has revolved around the response to the COVID-19 crisis.
The Anjou location will provide LaunchWorks with both increased capacity and strategic alignment with the LaunchWorks business continuity strategy. The LaunchWorks Anjou location is co-located with sister company, Cryopak, a leader in temperature control packaging and monitoring solutions.