Medical Device Testing
SGS Polymer Solutions is ISO 17025 accredited and FDA Registered. We partners with companies to assure that their quality needs are being met.
Our quality department is experienced in relating customer quality requirements with SGS Polymer Solutions’ quality system. All work at SGS Polymer Solutions is conducted under strict quality guidelines. We can conduct projects within cGMP requirements. Additionally, SGS PSI hosts client audits and visits as needed to satisfy quality compliance.
Approaches
Many of our programs are directed at providing data and information to assist clients with their quality control programs, quality assurance projects, or to support quality investigations.
SGS Polymer Solutions offers a GMP compliance audit and report, which many of our regulated clients appreciate having performed on their projects. This audit and report is done through our Quality Control & Assurance Department. Representatives of quality evaluate sample handling, environmental conditions, any outsourced testing, test equipment (calibration, qualification, verification, or validation), training records, lab notebooks, data and calculations, and any quality actions during the project. They provide a report documenting this audit, which is sent to our clients concurrently with the technical test report. This is a more formal documentation of our Quality Control checks specific to each client’s project.
Our wide scope of capabilities can be used to address Quality Control (QC) or Quality Assurance (QA) concerns, challenges, or investigations.
Experience
Work we’ve done:
- Verification of supplier Certificate of Analysis
- Release testing
- Developing specifications
- Root cause analysis
- Method validation and transfer
Sample Considerations
The submission of a sample will depend on what testing capability is needed. Contact an expert to discuss your specific sample considerations.