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CMDCAS Compliance Assistance |
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CMDCAS (Canadian Medical Devices Conformity Assessment System) is the Canadian equivalent of the 'CE' Marking
within the EU. Device manufacturers wishing to market devices within Canada MUST comply with the CMDCAS requirements.
TQMUSA/ECP, Inc. have certified CMDCAS- approved Lead Auditors on our team; let us assist you in achieving your Canadian approval.
For more information, please fill out our Information Request Form.
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CMDR Pre-Assessment Audits |
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One requirement of the Canadian approval process (CMDCAS) is to develop a quality management system that complies
with their CMDR. Are you prepared for such an audit? Don't leave this to chance; repeat audits due to initial
non-compliance are very expensive. Let TQMUSA/ECP, Inc. perform a Pre-assessment/ Gap Analysis to determine the
readiness of your quality system (utilizing our Canadian-approved Lead Auditors). For more information, please fill out
our Information Request Form.
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New Device Application / Registration Assistance |
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The Canadian approval process for medical devices requires a device APPLICATION/ REGISTRATION.
There are specific requirements and formats for how such an application must be submitted.
Let TQMUSA/ECP, Inc. assist you in formulating your device application. For more information, please fill out
our Information Request Form.
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MDR Assistance |
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If your device is marketed in Canada, and has been involved in an incident/near incident where a
patient/user has been injured, COULD have been injured, and /or has died, the Canadian
authorities MUST be informed. TQMUSA/ECP, Inc. can assist you in reporting such an MDR (Medical Device
Reportable) incident. For more information, please fill out
our Information Request Form.
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Assistance with selection of 3rd Party Assessment Body |
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Once your quality system has been implemented, and you're now seeking a third party, Notified Body /
Registrar, who do you turn to? There are literally hundreds of these 3rd Party Organizations vying
for your business. TQMUSA/ECP, Inc. have worked closely with ALL of the most reputable bodies; so let
us assist you in selecting a long-term "partner." For more information, please fill out
our 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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