QUALITY STANDARDS

1. FDA Registered.

2. cGMP compliant processes and facility

3. ISO 9001:2015 and 13485:2016  Quality Management Systems

4. Detailed Standard Operating Procedures.

5. Comply with all applicable regulatory and trade compliance requirements.

6. Training program for all employees in place and documented.

7. Robust change control and risk management processes.

8. Continuous quality improvement processes

9. Controlled environment packaging and storage

QUALITY MANAGEMENT SYSTEM

1. QCBD software suite QMS

2. Manage document changes, revisions and deviations.

3. CAPA - Manage corrective and preventive action processes

4. Training Management.

5. Supplier Management.

6. Customer and Field Complaints

7. Nonconforming Material Control

8. Equipment Management

9. Disaster Recovery Plan