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| International Regulatory Compliance |
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ISO 13485:2003 and/or ISO 9001:2000 |
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ISO 9001: 2000 is a quality Management system that can be applied to any type of business/organization. Its
primary focus is on a process approach; focusing on customer satisfaction, continual improvement and ongoing
measurement and analysis of collected data. ISO 13485: 2003 was specifically developed to serve the medical
device industry. Known as "twin sisters" these international standards are similar, however they are stand-alone
standards in their own right. ISO 13485: 2003 forms the backbone of many compliance programs, such as 'CE'
Marketing and Canadian 'CMDCAS' approval. TQMUSA/ECP, Inc. have been assisting clients to transition from the
obsolete versions of these standards to the current versions since their initial adoption. Let us assist you
in your quality assurance/regulatory programs. For more information, please fill out
our Information Request Form.
| Pre-assessment / GAP Analysis Services |
It takes determination and a great deal of effort, blood, sweat and tears to prepare
a quality management system. So WHY leave the final certification audit to chance? Be
prepared for the "real thing" by utilizing the pre-assessment services TQMUSA/ECP, Inc.
provide BEFORE your 3rd Party audit. Our certified Lead Auditors have over fifteen years
of experience in pre-assessing quality management systems; this pinpoints any potential
weak spots BEFORE an audit, thus allowing an organization the focus it needs to work on
those areas most needing resource.
Information Request Form.
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| Quality System Management Consultancy |
TQMUSA/ECP, Inc. have been instrumental in guiding many hundreds of clients to ISO certification.
Over the past twenty years, we have developed "Management Methods" that assist in bringing a
client to ISO readiness in the quickest way possible. These methods have stood the test of
time; our motto is: "Don't Re-invent The Wheel". Let TQMUSA/ECP, Inc. develop your system using
these methods, and by following our client-specific project planning.
Information Request Form.
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| QA / RA Outsourcing tailored to your needs |
Many organizations just cannot afford to employ a full-time, QA/RA specialist to maintain
their quality management system / regulatory compliance. Through close relationships built
over many years of mutual trust with our clients, TQMUSA/ECP, Inc. have developed specific
outsourcing services that support a clients future compliance. Very often the annual cost
of outsourcing is approx. a quarter of the cost of a full-time employee, so the economics
of this service speak for themselves.
Information Request Form.
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| Supplier Audits |
The raw material/component/service supplier chain built up by a client can be a vulnerable
partnership; often suppliers change their practices, materials/components without even
informing their customers. In order to maintain a certain degree of control AND confidence
in their suppliers, and to specifically comply with ISO 13485:2003 supplier requirements
for medical device manufacturer's, TQMUSA/ECP, Inc. have been performing supplier audits for
our clients for many years. Don't leave this critical activity to chance; call in our expert
Lead Auditors to perform your supplier audits and provide you with a detailed "diagnosis"
of your suppliers' business practices.
Information Request Form.
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Call 321.446.4438 or 240.631.8558
24 hrs/day, 7 days/week
TQMUSA/ECP, Inc. was established in 1992 to assist small and medium-sized businesses in achieving compliance for
the sale of medical devices in the USA and overseas.
Our well-qualified consultants offer complete solutions
ranging from the creation and implementation of Quality Systems through Technical Construction file creation
as well as offering services such as Authorized European Representation and assistance with the selection of a
Notified Body.
at your convenience to set up a free phone
consultation so that we may determine if one or more of our services will benefit your organization.
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