Medical Devices

Ora’s integrated approach to ophthalmic device research and development has made us the leading ophthalmic CRO and a trusted resource for clients around the world.

The current device market is favorable for innovation due to the demand from an aging population and the supply of new technological advances; yet an increasingly strict regulatory environment can lengthen timelines and increase costs.

Now more than ever, you need a CRO with end-to-end experience, encompassing scientific, business, clinical, and regulatory expertise. At Ora, our 30 years of ophthalmic scientific and business experience have made us experts in identifying precise market opportunities. Our clinical trial execution capabilities and global network of investigator sites allow us to execute trials faster and maximize your success rate. And our years of experience interacting with the FDA, EMA and PMDA provide us with valuable insights that allow us to anticipate and overcome regulatory hurdles early on in the development process.

Ora’s integrated approach can take you throughout the ophthalmic product development clinical-regulatory pathway with a full suite of tailored services:

  • Strategic Consulting
  • Technical and business due diligence
  • Identification of new predicate devices
  • Software verification and validation
  • Post Marketing and Advertising Services
  • Design and creation of Normative Databases
  • Clinical development strategy, study design and turnkey study management
  • Comprehensive regulatory consulting, interface with international regulatory agencies, briefing package preparation, and ongoing regulatory support

Diagnostic Devices

Our in-house capabilities are geared towards accelerating your development timeline to improve your chances of preclinical and clinical success for diagnostic device approval.

We offer four distinct advantages that help you launch trials faster, avoid delays within each engagement, and maximize the probability of study success:

  1. Large, active database of pre-screened research subjects across multiple disease states, ensuring rapid subject enrollment
  2. Up-to-date regulatory guidance in understanding increasing FDA demands for clinical research to support Class II predicate filings
  3. 30 years of experience in every aspect of the Research and Development Process
  4. Integrated regulatory/writing team incorporated in the clinical team from the start, ensuring smooth transition to the filing of the 510(k)

 

As a trusted partner in early stage product development up to registration studies, our therapeutic knowledge has led to innovative products in the following areas:
  • OCTs
  • Tonometers
  • Spectral Microscopes
  • Confocal Microscopes
  • Image Analysis packages

 

Surgical Devices

Partnering with Ora for surgical device development means that your vision and message are well represented with investigators. We act as an extension of our sponsors to ensure enhanced working relationships between client, CRO and investigators throughout the entire development, clinical and regulatory process.

Our clinical advantages include a Site Network that enables us to enroll studies quickly, utilizing experts and Key Opinion Leaders specific to your therapeutic area. Ora’s dedicated staff and SOP’s deliver superior project management and protocol adherence.

As a trusted partner in early stage product development up to pivotal studies, our therapeutic knowledge has led to innovative products in the following areas:
  • Femtosecond Lasers
  • Excimer Lasers
  • IOLs

 

Regulatory

Ora’s 30 years of regulatory experience has made us a trusted ophthalmic resource for our clients around the globe. Our integrated regulatory experts and writing team work together for a smooth transition from clinic to regulatory filing for medical devices.

We offer consulting and regulatory guidance in the following areas:
  • Establishment registration
  • Medical Device Listing
  • Device Classification requests (513(g))
  • Scientific Advice Meetings
  • Pre-Submission Packages
  • IDE Submissions ( including protocol development)
  • CE Marking
  • Premarket Notification 510(k)
  • Premarket Approval (PMA)
  • Investigational Device Exemption (IDE)
  • Quality System (QS) regulation
  • Labeling requirements