Questionnaire:In Vitro Diagnostic Directive and/or quality system certification

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A)Company information:
Company name: / Phone:
Legal address (street & no.): / Fax:
City/town & postal code / PO Box no.:
Region/state: / Homepage: / www.
Country: / e-mail:
Contact person: / Shift system: / No Yes, 1 shift a dayYes, 2 shift a dayYes, 3 shift a dayYes, 4 shift a day
Position of contact person: / Date: / YYYY-MM-DD
B)Sites related to the device(s):
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 Contract sterilizerSub.Mfg. Incl. Special ProcesSub.Mfg. Excl. Special ProcesMarketing & SellingDesign facility Complaint HandlingCustomer supportStorage facilityEU representative
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 / Supplied products/process
6
7
8
C)Product information (only relevant in relation to CE marking):
ID / Product name, description & IVD codes*1 / Intended use / 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

*1See NBOG F 2012-2 (

D)Route to CE mark (only relevant in relation to CE marking):
Product category
(select relevant) / Assessment route applied for (type of annex)
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 Presafe / 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
EN ISO 9001:2008ISO 13485:2003EN ISO 13485:2012DS/EN ISO 13485:2016EN ISO 13485:2016ISO 13485:2016None
EN ISO 9001:2008ISO 13485:2003EN ISO 13485:2012DS/EN ISO 13485:2016EN ISO 13485:2016ISO 13485:2016None
EN ISO 9001:2008ISO 13485:2003EN ISO 13485:2012DS/EN ISO 13485:2016EN ISO 13485:2016ISO 13485:2016None
EN ISO 9001:2008ISO 13485:2003EN ISO 13485:2012DS/EN ISO 13485:2016EN ISO 13485:2016ISO 13485:2016None
Description of the products and product categories:
H)General information:
Number of audits per year / Two Per YearOne per year
Language of communication withPresafe / DanishEnglish
Language of quality manual / DanishEnglish
Language of technical documentation / DanishEnglish
Consultant involved in the quality management system / Specify Name
I)Notes & additional information:
Specify:

Please send the completed questionnaire by e-mail to:

Presafe Denmark A/S

Tuborg Parkvej 8

2900 Hellerup

Denmark

Phone: +45 3945 4999

Email:

© Presafe 2017-02-27
BL 6.0-020E v14.0 / Tuborg Parkvej 8
DK-2900 Hellerup Denmark / Phone: +45 3945 4999
E-mail:
Website: / Presafe Denmark A/S
Notified Body: 0543
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