Healthcare Industry News: Cook Inc
News Release - January 23, 2007
Cook Medical Names 30-Year Veteran April Lavender Senior Vice President, Regulatory Affairs, Cook Inc.BLOOMINGTON, Ind.--(HSMN NewsFeed)--April Lavender, a 30-year veteran of the Cook Medical organization with extensive experience in the company's medical device global regulatory affairs operations, has been named senior vice president, regulatory affairs for Cook Inc.
Lavender was the vice president for regulatory affairs before taking on the title of senior vice president. April joined the Cook organization in 1976 where eventually she became the Manager for Operations of the Quality Control Department of the company.
"When Cook first produced medical devices, the government and regulatory oversight was not as strong as it is today. Today we operate in a business environment where the cost of obtaining regulatory approval for a new product is often in the tens of millions of dollars," said Kem Hawkins, president of Cook Inc. and Cook Group Inc. "April Lavender's sterling leadership in this area has played a significant role in Cook's success at introducing not just new products, but entire new families of technologies such as our endovascular stent grafts, in the U.S. and most other major medical markets worldwide. I am proud to announce this promotion, and know that under her supervision our regulatory efforts will continue to help the company meet its promises to our customers and their patients."
"This has been an extremely challenging and rewarding time to be involved in the regulatory affairs processes required to gain market approval for new medical devices," Lavender said. "Being named senior vice president at a company like Cook which puts the needs of the patients first and foremost is a genuine honor to me."
Lavender has nearly three decades of experience in the medical device industry and is both a certified regulatory affairs professional (RAC) as well as a certified lead auditor. She is a member of the Indiana Medical Device Manufacturers Council (IMDMC), the Regulatory Affairs Professional Society (RAPS), the American Society for Quality Control (ASQ) and the Society of Clinical Research Associates (SoCRA). She has participated in several public FDA advisory committee meetings and participated in compliance activities including Quality System (GMP) and Bioresearch Monitoring (BIMO) inspections on behalf of the Cook organization.
The world's largest privately held manufacturer of medical devices with international headquarters in Bloomington, Ind., COOKŪ (www.cookmedical.com/) is a leading designer, manufacturer and global distributor of minimally invasive medical device technology for diagnostic and therapeutic procedures. Since its founding in 1963, Cook has created innovative technologies for drug-eluting and bare metal stents, aortic and vascular endografts, catheters, wire guides, introducer needles and sheaths, embolization coils, medical biomaterials and contract manufacturing of biopharmaceuticals, vena cava filters and other minimally invasive medical devices for radiology, cardiology, urology and women's health, critical care medicine, surgery, gastroenterology, bone access and endovascular therapies.
Source: Cook Medical
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