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Quality Control At Bio-Concepts

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 corrdctions 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.

Bio Concepts
Product Support Commitment

Bio-Concepts is the only manufacturer of custom compression garments in the burn rehabilitation field that is also a certified Medicare Provider.

Bio-Concepts Custom Compression Garments are fully warranteed for 30 days after the patient has received the garment for all defects in materials, workmanship, or design. This includes alteration of returned garments or full replacement.

The Bio-Concepts commitment to satisfaction is where we shine above the others. If you are having a problem with one of our garments we want you to call or email us right away.

Contacting Bio-Concepts about a problem is as easy as ordering, You always get to speak with human beings and you can almost always speak to the person who designed your garment right away.

To Correct A Problem Call: 1-800-421-5647, or email  bio-con@bio-con.com.

An Interview with Paul Silverstein, MD
An Interview with Dr. Paul Silverstein, MD

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