Quality Standards

Bioseal assumes full responsibility for the integrity and sterility of our products.

We are a US based, FDA licensed medical device manufacturer, regulated by USFDA 21CFR 820.

According to the definition of a medical device given in the U.S. Food Drug and Cosmetic Act, a device is:

* An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them; or

Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or

Intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

Bioseal’s has performed extensive validation work on both Gamma Irradiation and Ethylene Oxide Sterilization processes  Our quality system is in compliance with industry standards, such as ANSI/AAMI ST67, ANSI/AAMI /ISO11137, and ANSI/AAMI/ISO 11135.

 

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