Donor eligibility determination has historically been one of the areas in the tissue industry to receive the most scrutiny by the FDA. There is a significant amount of data that can be difficult to collect and many changing variables that go into the decision making process that ultimately determine the acceptance of a donor. Incorrect donor eligibility determinations can result in tremendous liability risk and loss of revenue.
Services
Consulting
Reglera LLC was formed in November 2002 as a Consulting and Outsourcing services provider to the Medical Device Industry after operating since inception as Enscicon Biomed. The company is a wholly owned subsidiary of Enscicon Corporation, a technical services and staffing company, serving a variety of technical industries since 1994. The business model developed for Reglera was the final result of more than eight years of work with customers in the Medical Device / Bioscience Industry and is intended to directly address the major drawbacks of the most prevalent consulting model used in this industry segment while providing clients with highly valued regulatory expertise.
Outsourcing
Regulatory expertise is an absolute necessity in the biomedical marketplace. The medical technology industries can no longer afford a layered systems approach to achieving regulatory compliance. Organizations in regulated industries need to possess expertise, at a low cost, in order to successfully integrate their operational and regulatory requirements into holistic, efficient systems. However, balancing this need with the cyclic nature of the work combined with limited expertise often results in poor resource utilization.
