Devices & Diagnostics

Invacare hires chief compliance officer

Home health equipment maker Invacare (NYSE:IVC) has hired a chief compliance officer who previously held the role with Endo Pharmaceuticals (NASDAQ:ENDP). Colleen Craven’s role will be to ensure that Invacare is compliant with “relevant laws and regulations regarding the design, manufacture and distribution of medical devices,” according to a statement from the company. Invacare’s regulatory […]

Home health equipment maker Invacare (NYSE:IVC) has hired a chief compliance officer who previously held the role with Endo Pharmaceuticals (NASDAQ:ENDP).

Colleen Craven’s role will be to ensure that Invacare is compliant with “relevant laws and regulations regarding the design, manufacture and distribution of medical devices,” according to a statement from the company.

Invacare’s regulatory compliance — or lack thereof — came into focus in January when the U.S. Food and Drug Administration sent the company a warning letter for failing to adequately investigate reports of fires and sparks from electric beds that in some cases allegedly resulted in patient deaths.

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The company stressed at the time that it fully stands behind the safety of its products. “The FDA warning letter does not state that our products are unsafe, nor has it impacted our production,” CEO Gerald Blouch said. “The letter is related to documentation procedures.”

Prior to working with Pennsylvania-based Endo, Craven spent six years with PricewaterhouseCoopers. With PWC, she was a regulatory consultant to healthcare companies.