Program & Project Management plus Quality & Regulatory Compliance Subject Matter Expertise under FDA, ISO, EU, CAN, AUS and Brazil regulations and standards. Providing service to the Medical Device, IVD, Combination Products and Pharma industries since 1992. Services include leadership and support for Compliance Improvement Programs, Quality and Regulatory Compliance updates or remediation, New Product Development (NPD), Design Controls, Risk Management, IT systems and ERP Implementation and Validation, Production & Process Controls, Purchasing & Supplier Controls, Process Improvements, and the resolution of FDA 483s, Warning Letters, and Consent Decrees. For Service Call: 937-272-0063