We can help you create your Quality System from start to finish or remediate your existing quality system. We have the experience, templates, and systems to make sure your Quality System is ISO 13485 compliant.
Some examples of the Quality System policies, procedures, and forms we can help you with:
- Quality Manual
- Document and Data Control
- Management Responsibilities
- Training and Qualification
- Equipment and Maintenance
- IQ/OQ/PQ
- Design and Development
- Risk Management
- Device Master Record
- Supplier Evaluation and Monitoring
- Purchasing
- Receiving
- Post Market Surveillance
- Corrective and Protective Action