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Foreign Correspondent |
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All foreign device manufacturers (who propose to sell their medical device(s) within the US) must appoint a foreign correspondent to act as a
facilitator on regulatory affairs issues. For more information, please fill out
our Information Request Form.
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510(k) Submissions |
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Does your medical device require 510(K) approval to market it within the USA? Not sure? Let TQMUSA/ECP, Inc. determine the best
"strategy to market" for your device(s). For more information, please fill out
our Information Request Form.
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Pre-Assessment / GAP Analysis on 21 CFR Compliance |
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Is your organization truly prepared for an FDA site inspection in accordance with 21CFR? Can you afford to gamble that it
is not and have to potentially pay financial penalties and/or risk devices being taken off the market? A pre-assessment /
gap analysis by one of our experts will determine your strengths and/or weaknesses BEFORE such an inspection takes place.
For more information, please fill out our Information Request Form.
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Assistance with 483 closure |
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Has your company been inspected by the FDA and issued a '483'? If so, responding to this incorrectly may escalate it
to a warning letter. Let TQMUSA/ECP, Inc. plan your response and your actions to limit the damage to your current/future business.
For more information, please fill out our Information Request Form.
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Assistance with warning letter strategies |
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If your organization has already been issued a Warning Letter, then it is imperative that you seek expert advice on how
to plan the corrective action strategy it mandates. Let TQMUSA/ECP, Inc. assist you on the specific response/action plan
requirements you MUST go through in order to ensure that the FDA accepts your future strategy. For more information, please fill out
our Information Request Form.
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Consultancy assistance on Quality Systems development |
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Are your customers continually asking for your ISO/CE certification? Do you worry about whether your current quality
system complies with 21CFR/ ISO/ CGMP/ QSR/ CE etc.? TQMUSA/ECP, Inc. have been developing clients' Quality Management
Systems for more than 15 years. Let us utilize our vast experience, alongside our Management Methods© templates,
to develop and implement your own unique management system in a fraction of the time it would normally take. For more
information, please fill out our Information Request Form.
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MDR / Corrections & Removals / Recall Assistance |
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When a medical device has failed to meet its specific requirements in some way, and an injury/death or even a
potential injury/death has/may occur, then it is the mandatory obligation of the manufacturer to report this to the
FDA. Even if you are not sure whether to report or not, TQMUSA/ECP, Inc. can assist you in determining the best/ most
appropriate strategy. Remember: the clock starts ticking from the moment a manufacturer "becomes aware of" such
incidents. Don't delay. Contact the experts. For more information, please fill out
our Information Request Form.
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