Questionnaire: in Vitro Diagnostic Device Directive And/Or Quality System Certification

DGM Denmark A/S

Questionnaire: In vitro diagnostic device Directive and/or quality system certification

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This application has 3 pages. Please fill in all relevant sections.

A)Company information:
Company name: / Phone:
Legal address (street & no.): / Fax:
Region/state: / PO Box no.:
Country: / Homepage: / WWW.
Contact person: / e-mail:
Position of contact person: / Shift system: / No Yes, 1 shift a dayYes, 2 shift a dayYes, 3 shift a dayYes, 4 shift a day
Date: / YYYY-MM-DD
B)Sites related to the devices:
ID / Name and address / Certificates (If any) / Emplo-
yees / Type of company and/or activity performed
The manufacturer, as specified above / Manufacturer
1 / Sub-Site of manufacturer OEM supplier EU representativeContract sterilizerSub.Mfg. Incl. Special ProcesSub.Mfg. Excl. Special ProcesMarketing & SellingDesign facility Complaint HandlingCustomer supportStorage facility
2 / Sub-Site of manufacturer OEM supplier EU representativeContract sterilizerSub.Mfg. Incl. Special ProcesSub.Mfg. Excl. Special ProcesMarketing & SellingDesign facility Complaint HandlingCustomer supportStorage facility
3 / Sub-Site of manufacturer OEM supplier EU representativeContract sterilizerSub.Mfg. Incl. Special ProcesSub.Mfg. Excl. Special ProcesMarketing & SellingDesign facility Complaint HandlingCustomer supportStorage facility
4 / Sub-Site of manufacturer OEM supplier EU representativeContract sterilizerSub.Mfg. Incl. Special ProcesSub.Mfg. Excl. Special ProcesMarketing & SellingDesign facility Complaint HandlingCustomer supportStorage facility
Critical Suppliers
6 / Sub-Site of manufacturer OEM supplier EU representativeContract sterilizerSub.Mfg. Incl. Special ProcesSub.Mfg. Excl. Special ProcesMarketing & SellingDesign facility Complaint HandlingCustomer supportStorage facility
7 / Sub-Site of manufacturer OEM supplier EU representativeContract sterilizerSub.Mfg. Incl. Special ProcesSub.Mfg. Excl. Special ProcesMarketing & SellingDesign facility Complaint HandlingCustomer supportStorage facility
8 / Sub-Site of manufacturer OEM supplier EU representativeContract sterilizerSub.Mfg. Incl. Special ProcesSub.Mfg. Excl. Special ProcesMarketing & SellingDesign facility Complaint HandlingCustomer supportStorage facility
C)Product information (only relevant in relation to CE marking):
ID / Product name and description / Intended use / Private
Label* / Annex II list A, Annex II list B or self-testing
1 / Annex II, List AAnnex II, List BSelf test device
2 / Annex II, List AAnnex II, List BSelf test device
3 / Annex II, List AAnnex II, List BSelf test device
4 / Annex II, List AAnnex II, List BSelf test device

* Also defined as: Own brand label

D)Route to CE mark (only relevant in relation to CE marking):
Product category
(select relevant): / Assessment route applied for (Annex XX)
Annex II, List A / Annex IV Annex V + VII
Annex II, List B / Annex III
Devices for self-testing / Annex V + VIIAnnex V + VIAnnex IV
E)Expected date for submission of documentation and audit:
Documentation / Date: / Notes
Copy of the Quality system to DGM / YYYY-MM-DD
Technical documentation / YYYY-MM-DD
Certification audit / YYYY-MM-DD
F)IVD batch verification (only relevant for CE marking according to Annex VI):
Question: / Answer / Notes / Notes
Requested verification Method / Statistical VerificationVerification of every products
Batch Identification
Batch Size (Pcs)
G)General questions and requirements with respect to quality system certification (only relevant if quality system certification is requested):
Certification to which standard(s) / Proposed scope
None EN ISO 9001:2000EN ISO 13485:2001EN ISO 13488:2001EN ISO 13485:2003
None ISO 9001:2000EN 13485:2000EN 13488:2000EN 46003:1999
None ISO 9001:2000EN 13485:2000EN 13488:2000EN 46003:1999
None ISO 9001:2000EN 13485:2000EN 13488:2000EN 46003:1999
Description of the products and product categories:
H)General information:
Number of audits per year / Two Per YearOne per year
Language of communication withDGM / DanishEnglish
Language of Quality Manual / DanishEnglish
Language of technical documentation / DanishEnglish
I)Notes & additional information:
Specify:

Please send the completed questionnaire by e-mail to:

DGM Denmark A/S

Tuborg Parkvej 8

2900 Hellerup

Denmark

Phone: +45 3945 4999

Email: