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...
Discover how Oxford’s team of experts completed product-specific and State-of-the-Art Literature Searches within four months. INDUSTRY Medical Device Pharmaceutical Consumer Products SERVICES Medical Writing SKILLS Clinical Evaluation Reporting The Challenge A...
Discover how the right Oxford consultants were able to provide support for a Data Integrity Remediation project when a client needed niche expertise. INDUSTRY Pharmaceutical SERVICES Remediation SKILLS ISO Compliance The Challenge A global pharmaceutical manufacturer...
Discover how Oxford’s expert consultants enabled a smooth production process by reviewing six months of inaccurate data. INDUSTRY Pharmaceutical SERVICES Quality Assurance Remediation SKILLS Empower V2 The Challenge A research-based biopharmaceutical company was in...
Discover how Oxford helped our client qualify 50 combination products in 3 years. INDUSTRY Pharmaceutical Medical Device Manufacturer SERVICES Commissioning & Qualification Product Development Remediation SKILLS ISO Compliance Project Management Test Method...
Discover how Oxford helped a medical device manufacturer start their MDR compliance journey the right way. INDUSTRY Surgical Instruments SERVICES European Medical Device Regulations (MDR) SKILLS Risk Mitigation & Management Quality Assurance The Challenge A...
