February 10, 2005 , Enfield , CT – Oxford Performance Materials, Inc. (OPM) has selected Medical Device Consultants, Inc. (MDCI) as its principal regulatory support firm. In this relationship, OPM will refer its clients who require regulatory assistance to MDCI. MDCI will also support OPM as it expands its product offerings to the medical device community.
“The advantage of working closely with one regulatory services firm is that both OPM and our clients benefit from the specialized accumulation of knowledge in a single firm”, said Scott DeFelice, President, OPM. “This collaboration results in faster approvals, lower costs and reduced burden on our clients internal staff. We interviewed many prospective firms and established three core requirements. Our partner had to have global capability, be focused on medical devices and be able to offer a broad portfolio of services. Only one firm excelled in these three critical areas and it was MDCI.”
“At MDCI we have a broad vantage into the medical device industry. New materials and technologies are transforming the marketplace. OPM is clearly an innovative firm on the biomaterials frontier and we are pleased to offer both OPM and their clients our many years of accumulated and highly relevant expertise”, said Sheila Hemeon-Heyer, Director of Regulatory Services, MDCI.
Founded in 1980, Medical Device Consultants, Inc. is a leading consulting firm and contract research organization focused on the needs of the medical device, diagnostics, and combination products industries. The company provides regulatory, clinical trial, and quality assurance consulting services to help clients worldwide achieve and maintain compliance with U.S. FDA, Canadian, European, and other international regulations. For more information, please visit www.MDCI.com .
Founded in March 2000, OPM has rapidly become an industry leader in the ultra-high performance thermoplastic polymers market. The firm's versatile OXPEKK®-IG polymers are designed to meet the United States FDA requirements for use in long term human implantable medical devices and have been tested in accordance with ISO-10993. For morel information, please visit www.oxfordpm.com
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