FDA Regulation Consulting

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Jim Dunning - President

Jim’s consulting career began in 2001 and he has consulted in quality and regulatory for companies ranging from Fortune 500 medical device companies to start-up medical device companies.

Over his career, he’s acquired a passion for start-up and small companies, especially those in regulatory distress. Jim has amassed significant experience in preparing 510(k) applications, developing complete Quality Management Systems, providing Quality System Training, and advising on quality, business, and leadership issues. The bottom line is Jim and his company, Delta Consulting Alliance, can help companies get new products to market, fix regulatory noncompliance and maintain compliance, and establish an integrated risk management system. Jim is a Senior Member of the American Society for Quality (ASQ), a member of the Regulatory Affairs Professional Society (RAPS). Jim and his lovely wife Anne are proud parents of two grown daughters, Katherine and Lauren, and one granddaughter, Ava Rose.

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Denny Reichert - Vice-President Operations

Dennis is a multi-faceted business executive from the automotive, defense, and aerospace industries. With a focus on operations and intra-organizational relationships, he brings more than 30 years of experience to Delta Consulting Alliance including management positions in product, process, tooling, and facilities engineering, manufacturing, sales, and human resources. He’s managed business units and had full P&L responsibilities in a wholly owned subsidiary of General Motors.

In addition to his primary responsibilities in these positions, Dennis actively participated in the development and implementation of an ISO 9000 global Quality Management System. That experience along with his varied background has enabled him to effectively consult with numerous organizations, small and large, in the implementation and maintenance of their Quality Management Systems. Dennis received his undergraduate degree in Industrial Engineering from GMI (now Kettering University) and his MBA from Youngstown State University.

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Jeff Morgan - Vice President Consulting Services

Jeff Morgan has over thirty years of combined clinical and research laboratory management and FDA/ISO 13485 experience.

His expertise includes Quality System development and auditing (FDA QSR, ISO 9001 and ISO 13485). Jeff also provides consultation in the areas of FDA 483 and Warning Letter remediation and response, 510(k) submissions, GXP Facility Compliance, and management of technology transfer and scale-up. Additional experience includes CLIA Compliance consulting services, validation protocol development, establishment of environmental monitoring programs, contamination control, and in-vitro diagnostics research and development consultation. He has also authored over 25 scientific publications and trade journal articles.