Here’s How We Do It

As a medical device manufacturer registered with the U.S. Food & Drug Administration we are required to keep very careful track of any and all of our products that do not meet customer expectations.

Analysis of a recent half year of production of Bio-Concepts custom compression garments found that only 1.4% did not meet customer expectations; 98.6% did. We produced nearly 10,000 custom compression garments in that period and only a little over one hundred were not performing.

Most importantly, during that same period, we had no complaints that rose to the level of severity requiring notification of the FDA. In fact, Bio-Concepts, in close to 40 years of custom compression garment manufacture, has never had an FDA reportable complaint.

These are statistics that any manufacturer of a custom-made medical device would love to have. So how do we do it?


By the time our custom compression garment orders make it to shipping they are typically signed off by more than a dozen clerical, design, and production personnel. Problems can be tracked very easily so corrections can be made.

Multiple Eyes On

Each of the many people involved in order production lend their eyes to the product to ensure that errors and problems are discovered and corrected right away.

Change The Procedures

Sometimes correcting a problem requires retraining and fine-tuning on the job performance. More often, though we find it is the procedure that is unclear or incomplete. That’s when we roll up our sleeves and get to work on the documentation and implementation of new procedures.