Ophthalmic Devices

Areas of Expertise

  • Contact Lenses
  • Diagnostic and Imaging Devices
  • Intraocular Lenses (IOLs)
  • Retinal Laser Surgery
  • Vision and Refractive Error Correction Devices

Ophthalmic Medical Device Development

Clinical Program Management

  • Dedicated clinical operations staff focused on device specific regulations, averaging 8+ years of experience in ophthalmology and medical devices
  • Oversight in all stages of a clinical study, from start-up and enrollment to closeout
  • Key integration of all relevant GCP and ICH standards as well as good documentation standards
  • Medical monitoring for protocol design, safety oversight and data fidelity

Biostatistics

  • Statistical Analysis Plan (SAP) development
  • Statistical programming (tables, listings, and figures)
  • Creation of analysis datasets (ADaM compliant) and SDTM dataset

Regulatory Strategy

  • Development plans
  • Clinical trial plans, including patient selection and statistical plans
  • Non-clinical development plans, including GLP testing and biocompatibility (ISO 10993)
  • Identification of key opinion leaders
  • Identification of relevant ISO/ANSI standards
  • Predicate identification

Data Management

  • Electronic and Annotated Case Report Form (eCRF/aCRF) design and development using CDASH and SDTM
  • eCRF Completion Guidelines (eCCG) development
  • Clinical database design and development in a validated, 21 CFR Part 11 compliant electronic data capture (EDC) system
  • EDC training and support for all system users

Unparalleled Clinical and Regulatory Experience

Ora’s device operations group has excelled at all levels of clinical research. The team has led all phases of clinical research to support regulatory filings.

PMA/HDE

10+ in recent years

  • Intraocular lens
  • Retinal implant devices
  • Surgical pressure measuring devices
  • Injectable vitreous substitute
  • Combination products – contact lens eluding drug delivery systems

510(k)

20+ in recent years

  • Optical coherence tomography (OCT)
  • Tonometers
  • Spectral microscopes
  • Confocal microscopes
  • AI platforms
  • Software devices
  • Diagnostic strip tests
  • Contact lens
IDE PACKAGE SUPPORT 10 in recent years
HUD APPLICATIONS 3 in recent years
EFS PATHWAYS 2 in recent years
PRE-SUBMISSIONS 30+ in recent years

Over the past 40+ years, Ora has played a significant role in the development of marketed ophthalmic products.

Our experience covers consulting projects and clinical trials in ophthalmology, and extends beyond therapeutics to our industry-leading experience in ophthalmic medical devices. In the last three years alone, we’ve had more than 30 FDA pre-submissions and more than 10 products submitted for marketing applications. Ora’s regulatory experts have long-standing, established relationships with the CDRH branch of the FDA and other international regulatory agencies. Ora is proficient in ophthalmic medical device regulatory consulting, including presubmission to FDA and conducting clinical trials to support marketing applications.