Exploring Health Care Clinic Services

A contract research organization (CRO) is tasked with testing medical devices or pharmaceutical products to determine if they are safe for use in the industry. Even though testing done by a CRO service is only one step in getting a medical device approved for market, it is one of the more pertinent steps because of all the work that goes into the process. If you have a medical device your company has developed that you are going to have tested by a CRO testing service, it is helpful if you know what to expect. Here is a look at some of the things that happen during CRO testing. 

The device will be assessed to make sure it meets regulatory standards. 

The FDA sets forth a complex guideline for anything that will be used in medical treatment or healthcare and understanding this guideline can be complicated if you do not have a lot of experience. One of the first things the CRO will do with your proposed medical device is to assess it to determine if it is compliant with regulatory standards. For example, they may look at whether the device is made out of materials that are safe for use by humans. 

The CRO will come up with a plan to properly test the device. 

Once the device has passed the initial assessment, the CRO will then usually proceed with the planning phase of testing. During the planning phase, the CRO will decide: 

• How it would be best to test the product in a clinical setting
• What types of study participants will be needed to test the device during a trial 
• How the device will be tested in a medically sound way to garner reliable data

This planning phase can take a while to achieve, but it is important that every detail is in place to ensure the product is tested properly to gain approval by the FDA. 

The device will be used in clinical studies or trials. 

The final phase of testing with a CRO will involve your proposed medical device actually being studied in clinical trials or studies. These formal research studies are designed to measure the efficacy and safety of the product by utilizing study participants that have been preselected. The study can involve multiple things depending on the product, and these studies may take a while depending on how the product is used. For instance, a device may have to be used by participants for several months to determine efficacy over the longer term. 

Reach out to a company like Pan Laboratories to learn more,