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| European Union - CE Marking |
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Authorized European Representation (EC - Rep) |
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All non-EU based medical device manufacturers, who intend to export their devices to the EU, (and who do NOT have a
place of business/ residence there) must designate an AER (Authorized European Rep.) to act on their behalf on
all regulatory affairs issues (eg. Vigilance reports). TQMUSA/ECP, Inc. have offices in the UK that can act as your
facilitator on such issues as device registration, vigilance reporting, etc. TQMUSA/ECP, Inc. have been representing
many device manufacturers' for more than 5 years. For more information, please fill out
our Information Request Form.
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General Medical Devices (MDD) |
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Devices that are sold within the EU, and that are NOT deemed as an IVD (Invitro Diagnostic; eg. Pregnancy Test
Kits sold "over the counter"- OTC) or an AIMD (Active Implantable Medical Device; eg. Pacemaker) fall under the
general medical device law; that being MDD 93/42/EEC. In order to display a 'CE' Mark upon your device, (the
minimum requirement for European acceptance) your device MUST comply with this law! TQMUSA/ECP, Inc. utilize our
highly qualified, certified Lead Auditors to assist your company in achieving this very important device
"Stamp of Approval". For more information, please fill out
our Information Request Form.
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In-Vitro Diagnostic Devices (IVDD) |
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If your device is categorized as an IVD (Invitro Diagnostic) device, in order to acquire the 'CE' Mark for
the EU, it must meet certain criteria (eg. Technical File; Risk Management Evaluation; specific labeling to
EN980: 2003, etc). Let TQMUSA/ECP, Inc. assist you in acquiring your 'CE' mark; we know the process so well,
we can very often achieve CE mark on a rapid path. For more information, please fill out
our Information Request Form.
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EMC/Low Voltage Electrical Safety Services |
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TQMUSA/ECP, Inc. are able to offer EMC/LV Electical Safety testing/solutions through our affiliate testing facility,
Washington Laboratories. Based in Gaithersburg, Maryland, USA, the Washington Labs has been assisting medical device
manufacturers to achieve US/NRTL listing (UL, TUV and CSA), EU/CE Marking and Canadian CSA compliance in accordance
with IEC 60601 for many years.
Information Request Form.
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Technical Construction File / Design Dossier Development |
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In order to achieve 'CE' Marking for your medical device (for EU distribution), AND for Canadian Compliance
too, your organization MUST develop a Technical Construction File (class I, IIa, and IIb devices) or a
Design Dossier (class III devices) as one of the critical elements to gaining said CE Mark/Canadian
approval. TQMUSA/ECP, Inc. have assisted over 300 organizations to develop their Tech. Files/ Design Dossiers;
from non- powered wheel chairs, to ocular implants; we can ensure CE/ Canadian Compliance. Don't leave
this critical activity to chance. Let our experts guide you through the many regulatory requirements
necessary (eg. Risk Management to ISO 14971:2000; Labeling to EN 980:2000, Essential Requirements
Evaluation, etc.). For more information, please fill out
our Information Request Form.
| Risk Management Compliance to ISO 14971:2000 |
Medical devices are now required to be evaluated against a known risk management standard;
ISO 14971:2000, if utilized, will allow a third party assessment organization to "presume"
compliance if completes correctly. Let TQMUSA/ECP, Inc. assist you with this critical activity,
by utilizing our mature Standard Operating Procedure with appropriate forms, in accordance
with this standard. Information Request Form.
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| Essential Requirements Compliance to Annex I of Directives |
Whether it is the MDD (general medical devices), or for the IVDD (In Vitro Diagnostic devices) that you
seek to comply to, Annex I of these EU laws mandate a medical device manufacturer to carry out an evaluation
of your device(s) against this/these requirements. TQMUSA/ECP, Inc., with certified Lead Auditors on our staff,
have been assisting clients with our pre-designed Essential Requirements evaluation matrix, for more than nine years.
Information Request Form.
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| Labeling Compliance Assistance to EN 980:2003 |
To ensure that you do not market devices which could be deemed as "adultered" (that is, with nonconforming
labeling information), and which could then be subject to a field recall, TQMUSA/ECP, Inc. have been providing
detailed device/label review services BEFORE a device is released to market. One such review saved a client
approx. $5,000 in lost inventory. TQMUSA/ECP, Inc. have been assisting clients to comply with EU law and
specifically EN 980:2003 (medical device labeling standard for CE mark compliance) for more than nine years.
Information Request Form.
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| Vigilance Reporting Assistance |
If/when a medical device fails in one form or another, it is vital that, if an injury (or even a potential
injury) occurs, then this incident MUST be reported correctly to the EU authorities quickly and accurately.
TQMUSA/ECP, Inc., as acting Authorized European Representatives (with offices in the UK) have been representing
many clients in such situations. Do not leave such a critical reporting requirement to chance. Let TQMUSA/ECP, Inc.
manage/coordinate this vital reporting activity.
Information Request Form.
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Assistance with Selection of 3rd Party Notified Body (NB) |
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Once our 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 Organization 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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