Case Study

Discover how Oxford’s consultants helped to remediate the issue and pass the FDA re-inspection. INDUSTRY Medical Device SERVICES Remediation Documentation Corrective & Preventative Action (CAPA) Quality Systems Improvement SKILLS FDA Compliance Quality Management...

Discover how Oxford provided assistance to keep the project on track. INDUSTRY Medical Device Manufacturing SERVICES Regulatory Affairs SKILLS EU MDR Compliance The Challenge When a European medical device manufacturer needed to achieve MDR compliance, they began the...

Discover how Oxford consultants revised a Quality Management System to meet FDA regulations within seven weeks. INDUSTRY Life Sciences SERVICES Quality Assurance Engineering Compliance Remediation Auditing SKILLS 21 CFR Part 820 & Subparts FDA Regulations Quality...

Discover how Oxford’s team helped create an FDA-compliant automated production process. INDUSTRY Medical Device SERVICES Automation Equipment Development Inspection Readiness SKILLS FDA Compliance Business Analysis Functional Analysis Specification Development Project...