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PASS
Engineering is a leading provider of visual localization
tools and technologies. Enterprises across the
globe benefit from the quality, consistency and
reliability of PASS's localization technologies.
Providing comprehensive support for all the major
development and localization platforms, including
Windows, Java, .NET, Palm OS, XML/XLIFF, and Borland
VCL, PASS Engineering is widely recognized as
a technological leader in software localization.
For more information, visit www.passolo.com
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| Obelis European
Authorized Representative Center (OEARC),
based in Brussels Belgium since 1988, is a quality-driven
(ISO Certified), service-oriented company assisting
non-European and non-US device manufacturers' successful
endeavors into Europe and the United States. Services
include integrated regulatory solutions for MDD
93/42/EEC,
IVD 98/79/EC, PPE
89/686/EEC, MD 98/37/EC,LVD
73/23/EC, EMC
89/336/EEC and Cosmetic
78/768/EEC European Directives. Obelis'
robust compliance network operates in Brazil,
China, Canada, USA, Israel, India, Australia,
and Malaysia, offering language compliance
solutions and superior international representation.
Manufacturers finally have "One Global Solution" for
their regulatory needs and new market penetration. |
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| CE
Marketing Consultancy
provides coordinated European
and American regulatory and quality strategic planning,
guidance and implementation from design and development
through to market launch, including all regulatory
documentation and submissions, for medical device
companies worldwide. Their clients include manufacturers
of high risk products such as pacemakers and catheters.
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Opticentre
is the world's first true facilitator of optimized hosted
workflow to enable enterprise clients to add velocity,
enhance quality, slash costs and realize simship on
their global release processes. Employing combinations
of the smartest programmers, language and workflow technology
experts and best-of-breed standards tools and technologies
such as Idiom, PASSOLO and Heartsome, Opticentre enables
the customer to benefit from and control future proof
globalization solutions now - without the capital investment,
change management and other issues which normally delay
such ideals. Find out more at www.opticentre.net.
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CGP
Europe, established in 1991, has mainly
specialized in high tech companies. Now we
offer any company, start up or well established,
the benefit of an attractive package managed
by a team of multilingual Public Relations
Specialists located in one central office in
Brussels, at the heart of Europe. The company’s
unique and competitive approach allows you
to select your European target markets and
work directly with CGP’s Centralized
European Team, each of whom is dedicated to their
own geographical territory based on their linguistic
skills.
Part of an international Network of PR Agencies,
CGP Europe also has close relations with companies
offering complementary services such as:
business developmet, EU lobbying, advertising,
venture capital, investor relations, web marketing,
human resources and much more…
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R&Q
Consulting Ltd. is a consulting company
which provides services in Quality Systems
and Regulatory Affairs for companies in
the medical industry and for healthcare
institutions: |
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Preparation and implementation
of Quality Management Systems compliant
with the current international standards,
the FDA Quality System Regulations, the
EC Directives, and the Canadian Medical
Device Regulations. |
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Training of personnel in implementation
of Quality Management System requirements. |
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Courses and presentations on GMP, environmental
control, sterilization, quality and regulatory
requirements. |
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Preparation of protocols and reports for
validation of equipment and processes. |
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Guidance in implementation of Risk Management
processes compliant with standard EN ISO
14971. |
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Assistance in preparation of the required
documentation for compliance with US, European,
Canadian and Israeli regulatory requirements. |
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Preparation of submission files for medical
devices and IV diagnostics to the FDA, the
European certification authorities and the
Canadian Therapeutics Products Directorate
in order to obtain marketing clearance. |
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Eisner
Safety Consultants: A firm helping medical device and
in-vitro diagnostic manufacturers through international
regulatory (FDA 510(k), CE Mark, Canadian Medical Device
Regulations (CMDR), European and other international
regulations) and product safety (IEC 60601-1 Series
of standards) processes. Eisner Safety Consultants is
a network of experienced professionals assembled to
provide support to clients for Quality Systems, Product
Safety, EMC, and International Regulatory Requirements.
They have many special tools to help our clients through
this process including the newly released EMC Marking
and Labeling Workbook for IEC 60601-1-2:2001. Contact
Eisner Safety Consultants at 503-244-6151 or Leo@EisnerSafety.com.
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UL
(US) Canadian & CE Marking Services
CertifiGroup provides US
and Canadian product certification to manufacturers
worldwide, in accordance with UL, ANSI, NFPA and
CSA Standards. CertifiGroup's Field
Labeling team has the most experience and fastest
response in the industry. Their SEMI
S2 evaluations and reports help worldwide manufacturers
of Semiconductor equipment meet SEMI S2-S14 requirements,
and their CE
Marking Services assist US manufacturers
with product compliance for the EU and beyond.
Their Certifications team will guide you through
evaluation and testing, and ensure your product
is ready for the market without delays.
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International
SEO
S.E.O. Advanced is a global marketing driven firm with
an experience base of over 6 years focused Online
Marketing penetration strategies and sales. They have
developed superior search
engine optimization techniques and specialize
in getting to know their clients needs so that they
can provide the most customized solutions. Along with
their vast expertise in search engine optimization
methods, S.E.O. Advanced offers superior website
design services. |
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