The WiscMed Wispr digital otoscope is a Class I medical device.
FDA registration for the Wispr can be found here.
As part of the FDA dictated process for Class I medical devices, WiscMed maintains extensive records relating to the conception, design, and implementation of the device. In addition, our vendors have all passed the required audits related to medical device manufacturing. We have had extensive third-party testing performed on the device to make sure the Wispr is safe to operate in the clinical environment.
Testing and certification information can be found in the specification and compliance sections of our instruction manual.
We follow stringent processes for any changes we make to the device. We have systems in place to monitor and report any adverse events from the use of our device.
We offer a two-week trial program after an approved evaluation form is received by WiscMed.
We also offer a quick, live, and insightful 15-minute demonstration. This is a great way to have any questions answered and see first hand some of the benefits of the Wispr Digital Otoscope.