drug development& medical devices
the Development of new Medicines & medical devices around the globe is highly regulated by a wide variety of Governmental agencies & institutions. three major authorities set the tone: Food Drug Administration, European Medicine Agency and Japanese authority regulating medicines & devices.
the toxicological pathologist plays an important role in this Regulatory process.
ophthalmic medical devices
FDA & Center for devices and radiologic health (cDHR)
There are various examples of Ophthalmic devices which need to follow a strict FDA approval path.
therapeutic: contact lenses & products
Prosthetic: keratoprosthesis, IOL, Aqueous shunts
Diagnostic: camera, tonometers, OCT devices
surgical: IOL, IO-gas, phacophragmentation systems