Sterling Medical Registration-Daniela Levy - Sterling Medical Registration

Quality Manual

Notified Body Reportable Changes Procedure

Quality Management Procedure

Management Review Procedure

Quality Records Procedure

Document Control Procedure

Customer Service and Contract Review Procedure

Training & Qualification Procedure

Customer Complaint Procedure

Customer Feedback & Post Marketing Surveillance Procedure [PMS ,PSUR, SSCP, PMCF]

Medical Device Reporting Procedure

Corrective and Preventive Action (CAPA) Procedure

Purchase Procedure

Suppliers' Control Procedure

Non‑Conformity & MRB Procedure

QC Inspection Procedure

Identification and Traceability Procedure

Calibration & Maintenance Procedure

Change Control Order ECO Procedure

Design Control Planning & Development

Design Control Verification & Validation Procedure

Design Control Transfer & Changes Procedure

Risk Management Procedure

Packaging Storage & Transportation Procedure

Data Analysis Procedure

Labeling Procedure

Quality Audit Procedure

Process Monitoring & Measurement Procedure

Medical Device / Technical File Procedure

Work Environment & Clean Room Procedure

Sterilization Validation Procedure

Unannounced NB Audits

Software Validation Procedure

Manufacturing Process Procedure

Equipment Processes Validation or Qualification Procedure

Clinical Evaluation & Clinical Investigation Procedure

EU MDR Special Responsibilities