Sunset Healthcare Solutions has passed the ISO 13485 and MD-SAP audit of its Chicago and Bloomingdale, Ill. facilities and will receive full certification this month.
Sunset manufactures a broad range of HME products with a special focus on sleep therapy supplies, oxygen items, nebulizers and related products and accessories.
The certification will help Sunset expand manufacturing capabilities to provide an array of medical products to international partners and their customers.
“This certification is our next step in establishing Sunset as a global medical device manufacturer,” said Sunset Quality and Regulatory Director Joe Consoli. “The outcome could not have been better.”
The company is currently working to obtain certification for its facility in Phoenix, Ariz.