1 Detailsabout manufacturer and contact person(s)
Manufacturer:Address:
ID No.:
VAT No.:
Phone No.:
E-mail:
Webpage:
Please enclose copy of Business Registration Certificate.
Contact person:Phone No.:
E-mail:
Statutory representative:
Phone no.:
E-mail:
Authorized EU Representative
(if applicable):
Address:
Phone no.:
E-mail:
Webpage:
2 List and classification(category) of products to be assessed*
Product Code / Intl. Recognised Nomenclature Code (UMDNS/GMDN/EDMA) / MD / IVD MDName and Description / Class / Category and Classification RulePlease enclose product information/brochures/instructions for use including detailed description of intended use of a product.
3 Applied conformity assessment procedure(s)
Directive No.: 93/42/EEC as amendedMedical Devices (MD) / Directive No.: 98/79/EC
In Vitro Diagnostics (IVD)
Annex II / Annex III.6
Annex II (excl. 4) / Annex IV (excl. 4, 6)
Annex VII + V / Annex IV
Annex VII + VI
Checkrespective Annex(-es).
Please enclose copies of already existing EC directive certificates.
To which standards would you like to certify your QM system?ISO 9001:2015 / incl. design and development of product
excl. design and development of product
Certification Scope:
ENISO 13485:2012 / incl. design and development of product
ISO 13485:2016 / excl. design and development of product
specific and other requirements
(e.g. sterilization process)
Certification Scope:
No certificate
If you have your system certified, please enclose copies of already existing QM system certificates.
4 Details about your quality management system
Name and address of the headquartersand subsidiaries / branches / Departments
Please fill the number of employees (approx.) in the respective departments / QC / DD / PU / PR / WH / SL / SE / Oth
Please enclose an organigram of the headquarters as well as of the possible subsidiaries/branches!
QC - Quality control DD - Design/Development PU - Purchasing WH - Warehouse
PR - Production SL - Sales SE - Service Oth – Other
Total number of employees: / Full Time: / Part Time:Shifts: / Number of employees on each shift
No. of shifts: / 1. shift: / 2. shift: / 3. shift:
Do you sell products under your own company name, which are produced by other companies? / yesno
If yes, did the original equipment manufacturer (OEM) already carry out a conformity assessment procedure? / yesno
Please enclose copies of already existing OEM EC certificates.
Place of specific processes
Processes / In house / Name and address of the process supplier (if applicable)Design/
Development
Production
Packaging
Sterilisation
Warehouse
Service
Critical material / Name and address of critical material supplier
5 Additional specifications about sterile products
Do you produce sterile products? / yesnoIf yes, which sterilisation procedure is used?
by ethylene oxide (EN ISO 11135-1)
by irradiation (EN ISO 11137-1) / by moist heat (EN ISO 17665-1)
other(specify):
Is the sterilisation process validated with the specified products? / yesno
6 Time scheduling
Please, specify your desired dates for(specify activity, see #3):Product(s)ecify ty, see #um na (špeicifkujte požadovanú službu) documentation review: / audit:
Completed by:
Date:
Please send the completed questionnaire to:
Ľubor Lysák3EC International a.s.
Hraničná 18
821 05Bratislava
SlovakRepublic / Phone: +421 2 5831 8343
+421918555771
Fax: +421 2 5831 8345
e-mail:
GDPR statement: According to the art. 6 sec. 1 let. b) of the Regulation (EU) 2017/679 of the European Parliament and of the Council on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (Lawfulness of processing), personal data of natural persons, which are stated in this document, are in 3EC International a.s. processed in order to take steps at the request of the Manufacturer, namely communication and correspondence with Manufacturer`s responsible personnel, which requests quote on conformity assessment of medical devices, prior to entering into a contract.
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