What is a Medical Device CRO?

A Medical Device Contract Research Organization is a CRO that specializes in the clinical trial, development, and data management of medical devices specifically.

A Contract Research Organization (CRO) is an organization contracted by another company to take the lead in managing that company’s trials and intricate medical testing responsibilities. Contract Research Organizations reduce the cost of research and development to help businesses and institutions save money while meeting evolving regulatory requirements. 

The medical device CRO industry has undergone tremendous growth over the last several years based upon an increased number of medical device trials and the number of regulatory requirements.

The design and implementation of medical device studies can vary significantly from clinical studies performed to support pharmaceutical products. Medical device CROs are able to offer services that are specifically designed to meet the trial needs and regulatory requirements that are unique to the development of medical devices and the expectations of the FDA and other regulatory bodies with respect to such devices.  

What Services Does A Medical Device CRO Perform?

Medical device CROs offers many of the same services as a Contract Research Organization or Clinical Research Organization tailored specifically to meet the needs of medical device development. 

Medical Device CROs provide a range of clinical research services that may include:

  • Medical Device Project Management
  • Clinical Data Management
  • Clinical Study Management
  • Research Compliance
  • Research Education
  • Validation Programming
  • Device Development Planning
  • Device Commercialization
  • Product Registration
  • Safety and Efficacy Summaries
  • Security Procedures
  • Quality Reporting
  • Case Report Forms (CRF)
  • Statistical Analysis Reports
  • Final Study Reports
  • Database Lock and Data Transfer
  • Database Maintenance and Archival
  • Medical Writing

Medical device clinical research is a rapidly evolving industry. It is crucial that all hardware, software, and internet-based applications are of the best quality in order to fast-track clinical trials while still maintaining quality control. Working with a CRO gives the hiring company access to these advanced technological resources, as well as systems for data management, research analysis, product development, and other clinical research services.