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Melita Ball
Founder & CEO at MBC & Affiliates, Inc. (MBCA)
Melita Ball is the Founder and CEO of MBC & Affiliates, Inc. (MBCA), a consulting firm specializing in regulatory and quality systems within the life sciences sector. She has over 30 years of experience in this field, with a strong focus on establishing compliant quality systems and leading teams through remediation projects. Her expertise encompasses global regulatory compliance requirements, including standards such as ISO 13485:2016 and various FDA regulations.12
Professional Background
- Current Role: Melita has been the CEO and Principal Consultant at MBCA since January 2006, where she provides consulting services to life sciences companies. Her work includes internal and supplier quality system auditing, FDA compliance training, and managing quality assurance programs.12
- Previous Experience: Before founding MBCA, she held several significant positions:
- Director of Quality Assurance at Hologic (2004-2006)
- Senior Manager of Regulatory Compliance at Ventana (2004)
- Senior Manager of Corporate Quality System Training & Documentation at CareFusion (2000-2004)
- Quality Assurance roles at Hollister Incorporated (1991-1997) .1
Education
Melita Ball holds a Bachelor's Degree in Philosophy from Bridgewater College, graduating Magna Cum Laude, and a Master’s Degree in Philosophy from The George Washington University.1
Areas of Expertise
Her areas of specialization include:
- Class I, II, & III Medical Devices
- In Vitro Diagnostics
- Medical Device Data Systems (MDDS)
- Combination Products
She is recognized for her ability to mitigate regulatory risks and improve business processes through effective quality management systems.12
