We have the analytical expertise and product testing experience needed to ensure safe and effective performance of a range of medical products and medical devices. We can provide validated testing for 510K submission and for pre-market approval.
We work with standard test methods and will develop and validate custom testing methods for your specific needs. SGS Polymer Solutions offers cGMP testing services on large or small projects. We are also FDA Registered, cGMP Compliant, and DEA Licensed. These quality credentials testify to our commitment to the most stringent of scientific rigor.
SGS Polymer Solutions offers a range of services including:
- Test method validation
- Pre market testing
- Lot release testing
- Packaging analysis
- Failure analysis
Our Medical Products testing experience includes:
- Biomaterials analysis
- Implants
- Medical device testing
- Disposable medical products
- Sterilization bags
- Bottles
- Stents
- Maxillofacial reconstruction devices
- Regenerative medicine devices
- Tissue engineering
- Drug delivery systems
- Tissue scaffolds
- Combination device testing
- Extractables and leachables testing on a variety of medical products