Juni 2013 - BISNIS STRATEGI DAN ISO SERTIFIKASI

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<span style="font-size: 20.0pt; line-height: 115%;"><b><u><i><a href="http://www.blogger.com/SIEN%20Consultants%20is%20a%20leading%20Consultant%20&%20Training%20firm%20for%20ISO%209001%20%7C%20Sertifikat%20ISO%209001:2008,%20QMS,%20Sistem%20Manajemen%20Mutu%20%7C%20Konsultan%20ISO%20&%20Pelatihan%20ISO%209001%20Terbaik%20No.1%20Indonesia." target="_blank">CE Marking</a></i></u></b> Of <a href="http://indokonsultan.com/consultants-ce-i-konsultan-ce-marking-i-training-ce-mark/" target="_blank"><b><i><u>MEDICAL DEVICES</u></i></b> Guide<o:p></o:p></a></span></div>
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<b><span style="font-size: 12.0pt; line-height: 115%;">                           </span><span style="line-height: 115%;"><span style="font-size: large;"> CONTENTS </span><span style="font-size: small;"><o:p></o:p></span></span></b></div>
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<span style="line-height: 115%;"><span style="font-size: large;">1.  Introduction
to the guide </span><span style="font-size: small;"><o:p></o:p></span></span></div>
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<b><span style="font-size: 12.0pt; line-height: 115%;">2.    Regulation <o:p></o:p></span></b></div>
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<b><span style="font-size: 12.0pt; line-height: 115%;">2.1.   European directives regarding medical devices / In </span></b></div>
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<b><span style="font-size: 12.0pt; line-height: 115%;">         VitroDiagnostic medical
devices and</span></b><b><span style="font-size: 12.0pt; line-height: 115%;"> their </span></b></div>
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<b><span style="font-size: 12.0pt; line-height: 115%;">         consequences for placing on the
market in the </span></b></div>
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<b><span style="font-size: 12.0pt; line-height: 115%;">         European Economic Area</span></b></div>
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<span style="font-size: 12.0pt; line-height: 115%;">2.1.1.   General <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">2.1.2.  <b><u> Scope of the directives </u></b><o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">2.1.3.   Essential requirements <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">2.1.4.   Importance of standards and their use <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">2.1.5.   <b><u>Problems of interpretation </u></b><o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">2.1.6.   Coordination of Notified Bodies <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">2.2.     Other directives to the taken into
consideration where applicable <o:p></o:p></span></div>
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<b><span style="font-size: 12.0pt; line-height: 115%;">3.       With LNE / G-MED, how do you obtain the
certificates required for CE marking ? <o:p></o:p></span></b></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.1.     Identification of the manufacturer and, where
applicable, of the other parties <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.2.     <b><u><i>Characterization of the products concerned
</i></u></b><o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.3.     Determining the applicable directive or
directives <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.4.     Determining the class of the device
(Directive 93/42/EEC case) <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.5.     <b><i>Choice of the conformity assessment
procedures </i></b><o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.5.1.   Assessment
procedures for directives 90/385/EEC (AIMD) and 93/42/EEC (medical    <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">             devices)
<o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.5.1.1.<b><i>
Examination of design (Annex II section 4) </i></b><o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.5.1.2. EC
type examination (Annex III) <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.5.1.3.
Full quality assurance system (Annex II) <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.5.1.4. <b><u><i>EC
verification</i></u></b> (Annex IV) <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.5.1.5.
Production quality assurance (Annex V) <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.5.1.6.<b><i><u>
Product quality assurance</u></i></b> (Annex VI) <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;"> 3.5.1.7. DEcleration of comfermity ( annex VII
) <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.5.1.8.
Particular case of software <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.5.2.   Assessment procedures for directive 98/79/EC
(in vitro diagnostic medical devices) <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.5.2.1.
<b><i><u>Design examination</u></i></b> (Annex IV section 4) <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.5.2.2. EC
type examination (Annex V) <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.5.2.3.
Full quality assurance system (Annex IV without sections 4 et 6) <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.5.2.4. <b><i><u>EC
verification</u></i></b> (Annex VI) <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.5.2.5.
Production quality assurance (Annex VII) <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.5.2.6.
<b><u><i>Product quality assurance </i></u></b><o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.5.2.7. EC
declaration of conformity (Annex III without section 6) <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.5.2.8.
<b><i><u>Verification of manufactured products </u></i></b><o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.5.2.9.
Particular case of software <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.6.       Horizontal themes <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.6.1.    <b><i><u>Risk analysis </u></i></b><o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.6.2.    Clinical evaluation <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.6.2.1.
Guiding principles <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.6.2.2.  Practical approach <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.6.2.2.1.
<u><b><i>The notion of "clinical data" is pointless : </i></b></u><o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.6.2.2.2.
Clinical evidence is obviously acquired from the start : <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.6.2.2.3.
The manufacturer provides sufficient data taken from the literature <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.6.2.2.4.<b><i><u>
The data consist of a clinical review. </u></i></b><o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.6.2.2.5.  Data from the literature are not available, or
not sufficient : <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.6.2.2.5.1.
Compliance with the regulation relating to the conduct of <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">                      the
clinical investigation <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.6.2.2.5.2.
<b><u><i>Pre-clinical</i></u></b> data and contents of the clinical investigations plan <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.6.2.3.   Examination of clinical data <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.6.3.     Devices placed on the market in sterile
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<span style="font-size: 12pt; line-height: 115%;">3.6.3.1.  <b><i><u>first possibility</u></i></b></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.6.3.2. Second possibility : <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.6.4.   <b><i>Establishing</i></b> biocompatibility <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.6.5.   Establishing microbiological safety <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.6.6.   <b><i><u>Devices</u></i></b> with a measuring function <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.6.7.   <b><i><u>Devices</u></i></b> that incorporate medicinal drugs <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">3.6.8.   Device previously considered as medicines
for placing on the market <o:p></o:p></span></div>
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<b><span style="font-size: 12.0pt; line-height: 115%;">3.7.     Course of the procedure with LNE / G-MED <o:p></o:p></span></b></div>
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<span style="font-size: 18.0pt; line-height: 115%;">4.       <b><i><u><a href="http://www.blogger.com/SIEN%20Consultants%20is%20a%20leading%20Consultant%20&%20Training%20firm%20for%20ISO%209001%20%7C%20Sertifikat%20ISO%209001:2008,%20QMS,%20Sistem%20Manajemen%20Mutu%20%7C%20Konsultan%20ISO%20&%20Pelatihan%20ISO%209001%20Terbaik%20No.1%20Indonesia." target="_blank">CE marking </a></u></i></b><o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">5.       <b><u>Maintaining</u></b> the advantage of CE marking <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">5.1.     <b><i><u>Full quality</u></i></b> assurance system <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">5.1.1.  Where product design examination has been
<b><i><u>carried</u></i></b> <u><i><b>out </b></i></u><o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">5.1.2.   General case <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">5.2.
<b><u><i>Production quality assurance </i></u></b><o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">5.3. Product
quality assurance <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">5.4. <b><i><u>EC type
examination </u></i></b><o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">5.5. EC
verification <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">5.6. <b><u><i>EC
declaration</i></u></b> of conformity <o:p></o:p></span></div>
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<span style="font-size: 12.0pt; line-height: 115%;">5.7.
<b><i><u>Verification of manufactured</u></i></b> products<o:p></o:p></span></div>
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