Services Offered by CERICON
FDA Issues and Enforcement Actions:
We work with your organization to maximize effective responses, development of action plans, remediation and clearance activities for:
- FDA Form 483s.
- FDA Warning Letters - Develop effective response, design remediation and clearance activities.
- FDA Consent Decrees - Work with the organization to fulfill the provisions of the decree and the development of remediation plans.
- Recalls, Corrections and Removals
- Serious internal or external audit findings - Assessment and Remediation activities.
Quality Systems
Quality Systems remediation, development and improvement to requirements of Quality System Regulation (QSR), ISO 13485 and other national and international standards.
- Conduct gap assessments and audits resulting in risk-based prioritized improvement plans.
- Conduct mock FDA Audits and preparation of the organization for FDA Audits.
- Train staff to quality system requirements.
- Prepare for and maintain CE Mark and compliance to ISO 13485.
- Design or redesign Quality Systems
- Management processes: training, personnel and management review.
- Design Controls: Design History Files, verifications and validations.
- Document Controls.
- Purchasing and Supplier Controls.
- Process Controls including Process Validation.
- Corrective and Preventive Action including Control of Nonconformities.
- Management Controls including Management Review, Training, audits.
- Control of Records: Document Controls, Device Master Record, Device History Records.
- Complaint Management, adverse event reporting (MDRs), records, trending, data analysis and Reporting.
- Acceptance.
- Statistical techniques.
Regulatory Compliance
Regulatory Compliance to FDA Title 21 Regulations
- Training of staff to regulations and requirements, customized to your company’s needs.
- Determine strategies for recalls, safety alerts and field corrections.
- Ensure proper registrations and listings.
Management Processes
Management and Business Process Improvement
- Management Review.
- Quality and strategic planning.
- Teamwork development.
- Crisis management and intervention.
- Project management.
- Data trending and analysis.
- Financial health.
- Defect elimination methods.
- Continuous improvement.
- Strategic management.
Contract Management
Short term fulfillment of Vice President and Director level management positions.
- Quality Assurance
- Regulatory Affairs