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21 CFR (CGMP, CGLP) General RA Principles |
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21 CFR (parts 820- Medical Devices CGMP and Part 58- GLP's) require that all employees are trained in
accordance with these laws, their own specific job- functions, and "typical" failures that may occur with
their devices as a result of poor workmanship/ supplied materials. For more information, please fill out
our Information Request Form.
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CE Marking Compliance (MDD and/or IVDD) |
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CE Marketing audits require all personnel to be suitably trained in ISO, MDD and/or IVD requirements.
Let TQMUSA/ECP, Inc. provide the necessary guidance/ training programs needed to ensure successful
assessment during a 3rd party audit. For more information, please fill out
our Information Request Form.
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CMDCAS Canadian Compliance (CMDR) |
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CMDCAS audits require all personnel to be suitably trained in ISO, CMDCAS requirements.
Let TQMUSA/ECP, Inc. provide the necessary guidance/ training programs needed to ensure successful
assessment during a 3rd party audit. For more information, please fill out
our Information Request Form.
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ISO 13485:2003 Made Simple |
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ISO 13485:2003 has a multitude of requirements. In isolation, they appear daunting and
confusing. Let our industry experts unravel the 'ISO' language into easy-to-understand everyday
situations that apply to your own business practices. For more information, please fill out
our Information Request Form.
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ISO 9001:2000 Made Simple |
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ISO 9001:2000 has a multitude of requirements. In isolation, they appear daunting and
confusing. Let industry experts unravel the 'ISO' language into easy-to-understand everyday
situations that apply to your own business practices. For more information, please fill out
our Information Request Form.
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Technical Construction File Development |
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Technical Construction Files (T.F.'s) have specific requirements that are mandatory when achieving
'CE' Marking for the EU. Many requirements are NOT clear when reading the EU Laws (eg. MDD 93/42/EEC).
TQMUSA/ECP, Inc. have internationally certified Lead Auditors who have many years of experience in actually
auditing such files. Who better than these auditors to assist in your T.F. development projects?
Let us assist you with your Essential Requirements, Risk Management, Labeling, device classification
evaluations. For more information, please fill out
our Information Request Form.
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Design Dossier Development |
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Design Dossiers have specific requirements that are mandatory when achieving 'CE' Marking for the EU.
A Design Dossier MUST be submitted to a notified Body prior to their on-site assessment. Many
requirements are NOT clear when reading the EU Laws (eg. MDD 93/42/EEC). TQMUSA/ECP, Inc. have
internationally certified Lead Auditors who have many years of experience in actually auditing
such files. Who better than these auditors to assist in your T.F. development projects? Let us
assist you with your Essential Requirements, Risk Management, Labeling, device classification
evaluations. For more information, please fill out
our Information Request Form.
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Process Approach "Mapping" Techniques |
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ISO 9001:2000 and ISO 13485:2003 are based upon a "Process Approach". It is imperative that your business activities are
mapped out in a sequential, common-sense approach. Our team of industry experts can either teach
students off-site in how to perform this task, or assist an organization, at their own facility,
to "map out" their current business practices. This activity forms the back bone of an organizations
quality management system, and is therefore a critical process that needs to be understood clearly
BEFORE the mapping process begins. Let TQMUSA/ECP, Inc. guide you through this critical activity. For more
information, please fill out our Information Request Form.
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