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MDCI helps you find the most cost-effective method for achieving quality goals and regulatory compliance. We work closely with you to design, assess, and implement the systems, procedures, and documentation to meet any of the regulations which affect your product: U.S. FDA Quality System regulation, ISO standards, European Medical Device Directives and Canadian Medical Device regulations.
KEY QUALITY ASSURANCE & COMPLIANCE SERVICES
Quality System Procedures and Systems Development and Implementation
- Corrective and preventive action programs
- Design control, including risk management and design validation
- Document control systems
- Software quality assurance
Process Validation Program Development and Implementation
- Master validation plans and protocol development
- Data analysis and report generation
Independent Third Party Assessments
- Quality system gap assessments
- Compliance audits
- Recidivist annual certification audits
- Due diligence
21 CFR Part 11 Compliance Services
- Targeted Training Services for:
- Management - Regulation Overview
- Regulatory, Quality, IT staff - Implementation Guidelines and Practices
- Quality and IT staff - Principles of Software Validation
- Implementation Planning and Assistance
- Gap Assessments
- Conformity Assessments
- Project Planning and Management
- Customized Audits to Ensure Ongoing Compliance
Regulatory Compliance Consulting Services
- Preparation for FDA inspections and registrar or Notified Body assessments
- Enforcement action responses and/or corrective action plans (483s, warning letters, etc.)
- Recall strategies
- Post-Marketing Surveillance (complaint handling, failure investigation, problem reporting, device tracking)
- Manufacturing and software information for FDA or Canadian submissions
- Technical File preparation for CE Marking
Internal Audits and On-Site Training
Temporary On-Site Quality & Compliance Staffing and Support
ISO 9001 and 13485:2003 Consulting Services
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