Regulatory Strategy & Testing - Orthopaedic & Medical Implants
We provide regulatory testing and rationale support for the orthopaedics industry. Our full range of complementary tests, method development and validation are designed to support OEMs in producing their regulatory documentation ready for successful submission.
Some examples of what we can do:
- Develop and write the testing protocols for regulatory submissions
- Compare dossiers from one regulatory submission against the requirements of another
- Wear Testing of Hips, Knees, Ankles, Shoulders, Wrists, and Elbows
- Static and Fatigue Mechanical Testing of all Orthopaedic Products
- Validate hydroxyapatite (HA) coatings against the FDA guidance
- Evaluation of porous metallic surfaces including additive manufacture (i.e. 3D printing)
- Establishing and validating cleaning processes
- Biocompatibility Testing
- Characterization of new materials for benchmarking
- Cleaning and Sterilization Validations for Reusable Devices and Instruments
- Establishing substantial equivalence
Our experts have a depth and breadth of experience of the requirements demanded by the FDA. If you are preparing for 510K submission then get in touch and discuss how we can support with third party testing, validation and troubleshooting. We find that FDA standards are the most sought after tests for orthopaedic devices, but we also work to other standards when required by you.
Having the rationale, and not just the numbers, means you will be better prepared for any push backs from the FDA or other regulatory bodies.
Lucideon's ISO 17025 accredited laboratories, and expertise in chemical, physical, microstructural, microbiological and surface analysis, ensures your orthopaedic implants are ready for regulatory submission.