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Management/QMS Representative |
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1 |
Manufacturer Information |
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1.1 |
Name and address of Manufacturer , name and address of Authorized Representative, all manufacturing locations, (excerpt commercial register or trading license) |
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1.2 |
Manufacturer’s EC Declaration of Conformity, Application or certificates, documentation Quality System EN ISO 13485 |
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1.3 |
DIMDI Notification according to §§ 25 and 31 MPG and Art. 10 of the Directive 98/79/EC. Form for certification information of IVD (Annex III to VII of 98/79/EC) |
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2 |
Product Description |
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2.1 |
Product description including all variations (photographs, advertising material or brochure) as well as a clear definition of the product and its accessories. |
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2.2 |
Definition of Intended Use |
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2.3 |
Classification and Conformity assessment procedure according to IVDD 98/79/EC. |
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2.4 |
Documents delivered/distributed with product: instructions for use, user manuals, (EN 591, EN 592), installation instructions, service documents, and maintenance instructions. |
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2.5 |
Labeling and Information |
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Labeling of and product information on the IVD product provided to professional users (EN 375) |
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Labeling of and product information on the IVD product provided for use of product by lay persons (EN 376, EN 13532) |
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Labeling requirements for IVD Instruments (EN 1658) |
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Model/makes/serial plates or labels, warnings, symbols used (EN 980, ISO 15223) |
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Assists |
Notified Body |
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Sales & Marketing/Shipping |
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Preparation |
Production/Manufacturing |
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Voluntary |
Research/Design & Development |
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Management/QMS Representative |
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2.6 |
List of standards applied, of Common Technical Specifications (CTS) and proof of fulfillment of essential requirements (CE essential requirement checklist) |
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2.7 |
Risk analysis and hazard management processes (EN ISO 14971, EN 61010-1-x, EN 13641), including graphs and summary of the risk analysis. Software security |
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2.8 |
Specified combinations with other products (product compatibility), module interfaces |
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3 |
Product specifications |
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3.1 |
List of components, instrument and assembly identification, parts list with manufacturer’s data |
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