EN | JPN | FR
EN | JPN | FR
Proven research models to deliver tomorrow’s breakthrough, today.
True to our mission of advancing ophthalmic product development, Ora has extended our expertise from therapeutics to a leading position in medical devices.
In the last 7 years, we have conducted 65 projects including 36 FDA Pre-submissions and 15 marketing applications — both IDE and 510(k).
With almost 150 years of cumulative experience, Ora’s seasoned medical device team has proven proficiency in ophthalmic medical device regulatory consulting, including pre-submissions to the FDA and conducting clinical trials to support marketing applications.
“Ora partners with ophthalmic medical device companies worldwide to advance diagnostic and therapeutic devices with a patient-minded approach to protect and restore vision. Our team offers technical expertise, passion for innovation, and a commitment to successful outcomes to improve patients’ quality of life.”
Artificial Intelligence
Contact Lenses
Diagnostic and Imaging Devices
Diabetic Retinopathy Screening
Intraocular Lenses (IOLs)
Pediatric Amblyopia and Myopia
Retinal Laser Surgery
Visual Acuity Testing Platforms
As Vice President of Clinical Operations, Anterior Segment & Medical Devices, Caitlin Black brings an incredible amount of industry knowledge and expertise to her role overseeing clinical operations, and regulatory strategy.
With over seven years at Ora, Caitlin has a deep understanding of development projects at every level, with prior roles including Clinical Project Manager and Associate Director of Clinical Operations. A certified Orthoptist, she also holds advanced qualifications in ophthalmic medical technology.
Vice President, Clinical Operations, Anterior Segment & Medical Devices
Ora’s Medical Device Regulatory group, led by Roger Albright, has consistently demonstrated excellence across all levels of clinical research.
With a robust background in the ophthalmic industry, Roger began his career as a Clinical Trial Assistant (CTA) at a contact lens manufacturer, gaining valuable experience in all facets of clinical development for both drugs and devices. Holding an MBA in International Business and as a member of RAPS (Regulatory Affairs Professionals Society), Roger brings a wealth of knowledge to the team. The Ora team, under Roger’s leadership, has successfully navigated all phases of clinical research to support regulatory filings.
Associate Director, Regulatory Programs, Medical Devices
10+ in recent years
• Intraocular lens
• Retinal implant devices
• Surgical pressure measuring devices
• Injectable vitreous substitute
• Combination products – contact lens eluding
• Drug delivery systems
• Canalicular plug
20+ in recent years
• Optical coherence tomography (OCT)
• Tonometers
• Spectral microscopes
• Confocal microscopes
• Femtosecond lasers
• Excimer lasers
• AI platforms
• Software devices
• Diagnostic strip tests
• Contact lens
• Dry eye devices
• Minimally Invasive Glaucoma Surgery
• (MIGS) devices
IDE Package Support
in recent years
HUD Applications
in recent years
EFS Pathways
in recent years
Pre-Submissions
in recent years
Ora, Inc websites use cookies. By continuing to browse the site you are agreeing to our use of cookies.
For more details about cookies and their use, please see our Privacy Policy.
