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A Word from our Staff
 Christine Shumard-Sauer, Ph.D. is Director at Protocol Link, specializing in the areas of global quality and regulatory compliance and continuous improvement with expertise in biotechnology/biologics, in-vitro diagnostics, informatics, risk management and quality systems. Chris has a Ph.D in Biochemistry/Molecular Biology from the University of South Florida College of Medicine and a B.S. in Biology/Immunology/Chemistry from the University of the Sciences in Philadelphia. Chris has a Lean Six Sigma Black Belt and has worked in the healthcare industry for over 20 years in R&D, Operations, and Quality Assurance.
"Now is truly an exciting time to be in the healthcare industry. This will be the era of the healthcare consumer where consumers will take charge of their healthcare more than ever. Personalized medicine and gene therapy will be more commonplace, and technological advances in the medical device arena will be exponential. Regulatory authorities will be challenged to keep up with the pace of innovation and consumer advocacy, and will rely on industry and consumer experts more than ever before. Industry will also need to rely on experts to help them navigate through the ever-changing regulatory landscape. The staff at Protocol Link is well-equipped to meet these challenges and ensure the best outcome for the client, the patient and regulatory bodies."
Christine Shumard-Sauer
Director
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"I am excited to join Protocol Link and believe a significant opportunity exists to build upon the company's strengths and strategies to create a more powerful operational platform that is poised for sustained growth. I am looking forward to working with organizations that can use Protocol Link's expertise in solving their business issues while continuing to set a new standard for performance. I look forward to partnering with the entire team to achieve our goals."
On April 29, the FDA announced the progress of the CDRH on its 2014-2015 Strategic Priority: "Strike the Right Balance Between Premarket and Postmarket Data Collection." As part of its Strategic Priorities, the CDRH established a goal of assuring the appropriate balance between premarket and postmarket data collection to facilitate and expedite the development and review of medical devices-in particular high-risk devices of public health importance. The CDRH established a target date of December 31, 2014, by which to review 50% of product codes subject to a Premarket Approval Application (PMA) to determine whether the FDA could (1) rely on postmarket controls to reduce premarket data collection, (2) shift some premarket data collection to the postmarket setting, or (3) pursue down-classification. The FDA reviewed 69% of the product codes by December 31, 2014, exceeding its 50% review target.
