- Establish 21 CFR 820 and ISO 13845 Quality System
- Provide short-term or interim Quality System maintenance
- FDA, Notified Body, and ISO 13485 registrar audit preparation and participation
- Prepare and assist with Medical Device Single Audit Program (MDSAP)
- Tissue auditing, licensing and registration
- Supplier and internal audits
- Conducting a strategic gap analysis
- Design controls implementation and completion of design history files
- Medical device reporting and vigilance reporting
- Labeling and instructions for use
- Promotional literature assessments including surgical techniques, brochures and websites
- Remediation resulting of audits or inspections
- Training and mentoring
Quality Management Systems
MRC Global’s consultant team will address your Quality System needs to ensure compliance with applicable regulatory requirements, including Domestic and International Medical Devices Regulations. MRC Global provides quality assurance consulting services to advise and create a quality management system in compliance with the regulatory requirements applicable to your product. MRC Global Quality Assurance capabilities include:
