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Should THIS be the Next Global Priority?

Should THIS be the Next Global Priority

Back in 2012 an article was published in PLOS titled “Strengthening Medical Product Regulation in Low- and Middle-Income Countries” which strongly suggests developing countries must become a global health priority. In fact, The World Health Organization (WHO) recognizes regulatory system functions as one of the six core building blocks of health systems.

The Value of Top Monitors

Monitoring Attributes

Monitors that perform their job at a high level can drive the growth and reputation of their company. The companies that employ these monitors are equipped to meet the needs of their clients and ensure that patient safety and data integrity are maximized.

What Exactly Are Device-Drug Combination Products?

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The area of combination products is an exciting expanse of potential innovation and discovery for both the medical device and drug industries. But what exactly are combination products? According to 21 CFR 3.2(e), they are defined as:

5 Reasons Patients Withdraw from Clinical Studies

5 Reasons Patients Withdraw from Clinical Studies

In a clinical research, patients are the most important key to a study. Subject retention is vital for data integrity, and lack of subject participation can have costly delays for the Sponsor.  Since research sites spend a great deal of time and effort finding qualified subjects, they should also be equipped with reasons subjects withdraw to help prevent this from happening.

Cell Therapy: The Fourth Pillar of HealthCare

Cell Therapy   The Fourth Pillar of HealthCare

As the cell therapy market continues to grow, it’s important to note the similarities between medical device and cell therapy clinical trials. To help illustrate this, we’ve created an infographic, “Cell Therapy: The Fourth Pillar of Healthcare,” which is available for download.

What Makes a Device Class III?

What Makes a Device Class III

According to an article in “The Gray Sheet” the FDA is proposing new regulatory language to determine what devices designated Class III devices and not suitable for down-classification.

FDA Updates HDE Guidelines

FDA Updates HDE Guidelines

FDA is updating guidance on its humanitarian device exemption program to clarify an expanded profit allowance and a potentially less-restrictive upper-limit on the number of qualifying HDE devices that can be sold for profit in a given year.

1747 - James Lind

1747 - James Lind

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014 calendar year.

Do Device Post-Market Studies Follow 812?

Do device post market studies follow 812

It just depends!

Compassionate Use in Unapproved Medical Devices

Compassionate Use in Unapproved Medical Devices

When and how is compassionate use of unapproved medical devices allowed? The Federal Regulations explicitly state how an unapproved device should be used in a compassionate use situation by a physician. The FDA website also provides a training presentation on this topic.

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