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BE-ST is
FDA registered
and QSR (cGMP) and ISO 9001 compliant.
These
certifications help us ensure that we supply you with products
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 certification process.
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.
FDA cGMP Compliant
GMP—Good Manufacturing Practices.
cGMP—current Good Manufacturing Practices.
QSR—Quality System Regulations.
A series of quality systems and programs meeting the specific
regulations of the Good Manufacturing Practices as outlined
in the FDA Code of Federal Regulations.
As the regulating body for medical devices in the U.S.,
the FDA seeks to establish as 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
9001/ISO 13485
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 following 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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