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ISO
13485: 2003
ISO 13485: 2003
defines the requirements for a Quality Management System applicable to the
design and manufacture of
medical devices.
It requires the organization to demonstrate continuous improvement, properly
control work environment, address requirements for inspection and
traceability for medical devices, maintain pertinent documentation and
records, validate processes for sterile medical devices, assess risks
attributable to the medical devices, follow stringent design transfer rules
during product development, implement effective corrective and preventive
actions, etc.
CONSULTING PROFILE
For over 14 years we specialize in
design and implementation of Quality Management Systems compliant with ISO
9001 / ISO 13485, regulatory (FDA, Health Canada) and customer-specific
requirements. Our consultants provide comprehensive training, consulting and
hands-on assistance, which includes:
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analysis of company needs, applicable regulatory and statutory requirements
and, where applicable, customer specifications and expectations
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pre-assessment and gap analysis of existing Quality Management System
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design and integration of ISO 13485-compliant
Quality Management
Systems
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Quality Management System development and implementation action plan
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preparation of Quality Manual, policies, procedures/protocols in line with
ISO
13485 and, where required, GMP /cGMP - (current) Good Manufacturing Practices
requirements or customer-specific preferences
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Document Control, including applicable forms, templates, publications, etc.
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Control of Records, including Data Management, R&D, manufacturing, shipping,
traceability and pertinent Quality Control/Assurance Records
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research and assistance in preparation of the specifications, procedures and
standards
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validation and verification of processes and products, including Design
Qualification (DQ), Process Qualification (PQ) and Operational Qualification (OQ)
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Risk Assessment and Failure Mode and Effect Analysis, where required
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selection and customization of suitable software, where applicable
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step-by-step guidance and on-going advice throughout the program
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hands-on participation in Quality Management System implementation
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active participation in Internal Audits and Management Review activities
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preparation of the Quality Management System for assessment by the Registrar
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assistance during
Quality Management System assessment by the Registrar
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post-assessment follow-up support
BENEFITS:
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no hassles (and extra costs) associated with external training
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compliance with ISO 9001/13485 and other regulatory and statutory requirements
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trained and motivated personnel
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better documentation, repetitive processes, improved performance
TRAINING:
We offer
tailor-made training suitable for all employees. Our training is conveniently
performed in-house or at the suitable location near your premises. This approach
guarantees minimum disruption to your operations, and the training is delivered
at a fraction of cost when compared to the cost of the same training performed
externally. Our services are delivered at a level tailored to suit your needs
and the needs of your unique work environment.
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EXCEPTIONAL TERMS
Flexible
structure of compensation allows organizations to direct 20 -
40%
of their planned budgetary expenses towards other urgent business
needs while, at the same time, benefiting from comprehensive services,
assistance and organizational support provided by Quexx.
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FOCUS ON STARTUP COSTS
Quexx business strategy, semi-virtual corporate structure and
flexible
compensation plan are designed to minimize startup costs. Our
extensive professional network offers comprehensive range of services
delivered by competent industry experts who combine proven solutions of the
world-class organizations with the “out-of-the-box” innovativeness and
creativity.
Read
more…
 INTELLECTUAL
PROPERTY (IP) is the key asset of rapidly growing number of
organizations, in particular those focused on research, development and
commercialization of the leading-edge technologies. Intimate knowledge of
the market players and the critical access to the key decision-makers are
the cornerstone of our marketing strategy.
Read more…
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CIS CONTINUOUS
IMPROVEMENT SOFTWARE is a complete management and document control software
system that offers our clients a comprehensive cross platform solution to
manage their complete organization. We can set you up on CIS in less
than 48 hours. You may quit at any time with no obligation or set-up costs.
CIS use is simple with built in help files, more than 100 step-by-step
training videos, 24/7 Help Line and presentations. Read
more...
INTEGRATED CRM+ERP+WEB COMMERCE SOFTWARE
in a single world-class
online business
application which includes
customer relationship
management (CRM),
order fulfillment;
inventory,
accounting
and
finance,
product assembly,
ecommerce,
Web site
management and
employee productivity.
Manage companies with multiple subsidiaries from a single account which
handles different currencies, taxation and reporting requirements - at a
fraction of the cost.
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more...
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