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| BE Medical offers a wide
range of analytical
instrumentation services and
support. We supply quality
analytical laboratory
instruments, including HPLC,
PSS and AFM. |
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| BE Medical development
services capabilities will
put your project on a fast
track. Our fully integrated
services include design
exploration and conception,
development, design detail
and verification and process
development and validation,
along with the latest lab
testing and prototyping
tools available. We offer
pilot production labs to
initiate processes and
product development or
finalize products in support
of clinical trials or market
launches. We can also
provide regulatory planning
and support to facilitate
the review and approval
process. |
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| Medical Device
Companies in the USA
must comply with
many regulations.
The FDA requires
that all medical
device companies
implement Standard
Operating Procedures
to ensure compliance
with the Quality
System Regulation,
also known as
Current Good
Manufacturing
Practice (CGMP)
requirements. For
export to the
European Union, the
company needs to
comply with the
requirements of ISO
13485. In addition
to these Quality
Systems, the
individual products
must be cleared by
the FDA for
commercial
distribution in the
USA, or be issued a
CE-Mark for EU
distribution¡£BE
Medical Consultants
offers a full range
of services to the
healthcare industry.
Our services are
focused on assisting
medical device
across the globe
achieve regulatory
and standard
compliance with
U.S., European and
Canadian agencies
and organizations.
Our approach to
client service is to
provide our clients
with expert
consultants who are
armed with a proven
and flexible
consulting
methodology. This
approach enables us
to provide you a
customized service
that meets your
specific needs. |
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1108 Spring View Lane Plano, TX
75075 |
Toll Free: 800-553-9057 Fax:
732-412-4040 |
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