The eye is an exquisite organ both in structure and in function; so too is your ophthalmic medical device. At iuvo BioScience, our team of scientists appreciate the unique technical challenges of ophthalmic medical device design and testing and our goal is to help you bring your design to the clinic.
Based on the principles of ISO 10993-1, and with consideration of other regional regulatory guidances, our consulting services can advise in design control, develop your biocompatibility assessment strategy, and prepare safety assessments and other regulatory documents. Our technical staff is able to test your device, whether it be a screening assay or a GLP-compliant study, meeting the required endpoints for both the standard ISO 10993 standards as well as standards for your specific medical devices (e.g., ISO 11979-5 for intraocular lenses). Our testing services include:
- Material characterization
- Screening studies
- Biocompatibility testing.
Specifically for ocular studies, we recognize that clinical observations are often the most critical outcomes; therefore, our team of internal experts and external consultants are diligent in their observations and assessments, ensuring that your data is of the highest quality, and employ a variety of assessment tools including:
- Slit lamp microscopy with photographic capabilities
- Binocular indirect ophthalmoscopy
- Retinal imaging
- Tonometry (applanation, rebound)
- Esthesiometry
- Pachymetry
- OCT
- ERG
