As a Class 1 Medical Device Supplier, we are able to provide validation and documentation to support our sterility claims for all Bioseal Products.
Bioseal is a US-based, FDA-licensed medical device manufacturer, regulated by USFDA 21CFR 820.
The FDA’s definition of a medical 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 has performed extensive validation work on both our Gamma Irradiation and Ethylene Oxide Sterilization (ETO) processes. Our quality system is in compliance with industry standards, including ANSI/AAMI ST67, ANSI/AAMI /ISO11137, and ANSI/AAMI/ISO 11135.