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BE-ST
is registered as a Device
OEM with the US Food and Drug Administration as well as ISO 13485:2003
registered with the National Standard Authority of Ireland (NSAI)
including compliance with the Design Control clause. The
BE-ST Quality Management System complies fully with 21 CFR Part
820 Quality System Regulation.
These
certification achievements help us ensure that we supply you with
products and services that consistently meet the highest standards
throughout the industry and around the world. Because of
our experience, BE-ST offers valuable assistance to our customers
by facilitating the FDA device approval process. BE-ST is
completely versed in the conduct of verification and validation
activities related to product and packaging design as well as
sterilization.
FDA
Registration
BE-ST fully complies with all appropriate FDA regulations relating
to the registration of facilities which design and manufacture
medical devices and components.
As
the regulating body for medical devices in the U.S., the FDA seeks
to establish a set of guidelines and practices that ensure consumer
safety and sound manufacturing practices. BE-ST fully complies
with all appropriate FDA regulations relating to medical device
design and manufacture.
ISO
Compliance
ISO, the International Organization for Standardization, is a
worldwide federation of national standards bodies created to set
standards for similar technologies in different countries. As
a result of complying with ISO standards, BE-ST is committed to:
• Improve Product Quality and Reliability
• Monitor Health, Safety and Environmental Protection, and Reduce
Waste
• Provide Greater Compatibility and Interoperability of Goods
and Services
• Increase Distribution Efficiency, and Ease of Maintenance
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