Ron Schoengold

Senior Quality Scientist/Team Leader 

Ron has an illustrious career spanning more than 45 years in development and commercialization of compliant IVD products. He iscertified in regulatory affairs and has a proven record of accomplishment for integrating quality and regulatory requirements with technical, organizational and business development needs.  He offers critical advice on the effective commercialization and maintenance of medical products and services.Ron’s input contributes to current FDA policies governing diagnostic products.

He is as an advisor to the Larta Institute (National Institutes of Health, Commercialization Assistance Program), assisting companies awarded SBIR grants.  Schoengold has published, presented or contributed to more than 16 scientific publications including a book chapter on point-of-care testing.  He holds 8 patents related to point-of-care diagnostics.

Schoengold has specialized training and hands-on experience in development of screening and diagnostic products in gastroenterology (e.g., Hemoccult® colorectal cancer screening tests), infectious disease and point-of-care devices, reagents and test systems. 

Quality and Regulatory Expertise 

  • ISO 9001:2008, ISO 13485:2003, ISO 14971
  • 21CFR 820
  • Warning Letters, FDA 483s
  • Consent Decrees
  • GMPs
  • Regulatory Submissions: 510(k), 513(g), PMA
  • Quality System Audit and Training
  • Quality Planning
  • GCP Audit
  • Risk Analysis and Risk Management
  • Root Cause Analysis
  • Product and Process Validation


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