Questionnaire: Medical Device Directive And/Or Quality System Certification

Presafe Denmark A/S

Questionnaire: Medical 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:
Postal code & Town/City / 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 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
Special processes e.g. sterilization processes & type:
C)Product information (only relevant in relation to CE marking):
ID / Product name and description & GMDN Code / Intended use / See Note*1 / Private
Label*2 / Classification acc. annex IX of the MDD
Class / Rule
1 / Class IIIClass IIbClass IIaClass IsClass Im / Rule 1Rule 2Rule 3Rule 4Rule 5Rule 6Rule 7Rule 8Rule 9Rule 10Rule 11Rule 12Rule 13Rule 14Rule 15Rule 16Rule 17Rule 18
2 / Class IIIClass IIbClass IIaClass IsClass Im / Rule 1Rule 2Rule 3Rule 4Rule 5Rule 6Rule 7Rule 8Rule 9Rule 10Rule 11Rule 12Rule 13Rule 14Rule 15Rule 16Rule 17Rule 18
3 / Class IIIClass IIbClass IIaClass IsClass Im / Rule 1Rule 2Rule 3Rule 4Rule 5Rule 6Rule 7Rule 8Rule 9Rule 10Rule 11Rule 12Rule 13Rule 14Rule 15Rule 16Rule 17Rule 18
4 / Class IIIClass IIbClass IIaClass IsClass Im / Rule 1Rule 2Rule 3Rule 4Rule 5Rule 6Rule 7Rule 8Rule 9Rule 10Rule 11Rule 12Rule 13Rule 14Rule 15Rule 16Rule 17Rule 18
5 / Class IIIClass IIbClass IIaClass IsClass Im / Rule 1Rule 2Rule 3Rule 4Rule 5Rule 6Rule 7Rule 8Rule 9Rule 10Rule 11Rule 12Rule 13Rule 14Rule 15Rule 16Rule 17Rule 18
6 / Class IIIClass IIbClass IIaClass IsClass Im / Rule 1Rule 2Rule 3Rule 4Rule 5Rule 6Rule 7Rule 8Rule 9Rule 10Rule 11Rule 12Rule 13Rule 14Rule 15Rule 16Rule 17Rule 18

*1Animal Tissue, medicinal products, Human Blood/plasma derivates

*2 Also defined as: Own brand label

D)Route to CE mark (only relevant in relation to CE marking):
Device classes
(select relevant): / Assessment route applied for (Annex XX)
Class Is / Annex IV+VIIAnnex V + VIIAnnex IIAnnex VI + VIINA / Please note that class I devices which are not sterile or have a measuring function do not require Notified Body approval.
Class Im / Annex IV+VIIAnnex V + VIIAnnex IIAnnex VI + VIINA
Class IIa / Annex IV+VIIAnnex V + VIIAnnex IIAnnex VI + VIINA
Class IIb / Annex IV+VIIAnnex V + VIIAnnex IIAnnex VI + VIINA
Class III / Annex IV+VIIAnnex V + VIIAnnex IIAnnex VI + VIINA
Sterile Procedure Pack / Annex IV+VIIAnnex V + VIIAnnex IIAnnex VI + VIINA
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)Only relevant for annex IV Certifications/Lot verification:
Question: / Answer / Notes / Notes
Requested verification Method / Statistical VerificationVerification of every products
Lot/Batch or Serial Number identification of products
Batch identification
Batch Size (Pcs)
Production testing acc. to which standards:
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 13485:2012EN ISO 9001:2008EN ISO 13485:2003None
EN ISO 13485:2012EN ISO 9001:2008EN ISO 13485:2003None
EN ISO 13485:2012EN ISO 9001:2008EN ISO 13485:2003None
EN ISO 13485:2012EN ISO 9001:2008EN ISO 13485:2003None
Description of the products and product categories:
H)General information:
Number of audits per year / One per yearTwo Per Year
Language of communication withPresafe / 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:

Presafe Denmark A/S

Tuborg Parkvej 8

2900 Hellerup

Denmark

Phone: +45 3945 4999

Email: