The team at 8:28 Consultants possess more than 60 years combined experience in their field of expertise. Academic accomplishments include: Doctorate in Organizational Leadership, Graduate Studies in Management, Administration and Organizational Development. Undergraduate studies in Industrial Engineering. Certifications and credentials include: - Medical Device Regulatory Affairs Professional Society ISO 13485 Exemplar Global Lead Auditor - EU MDR Certified Auditor - ISO 9001:2008 Probitas Lead Auditor - AS 9100 Probitas Lead Auditor - CMMI Lead Assessor - Project Management Professional - Lean - Six Sigma Black Belt member - MBA Credentialed Adjunct Faculty