Contact and Business Details Company Name Website Street No. ZIP code City Country Province Contact person Function Phone e-mail Certification according to (mark with “X”) Quality Management System ISO ☐ without development ☐ without development, production etc. edition: 2012 2016 ☐ MDSAP ☐ TCP (Taiwan) ☐ PAL (Japan) Medical Device Directive 93/42/EEC Annex II Annex II, Section 4 Annex III Annex V Annex VI Others Remarks ∙ (please specify) Others Remarks ∙ Information about your Company Precise description of the parts locations which shall be certified Please give a brief description of the activities of your company that should be covered by a certification process (e. g. design, production, distribution etc.) Are you already certified? Yes No Please attach a copy of your certificate(s)! Which parts and locations of your company should be certified? Total no. of No. of people in the area of Shifts people Name Address of the unit site location facility shift Field per shifts Force time of of time Design Other No. No. Administration Technical Service Production Full Part people Please attach a current organizational chart of your company! Products Services, which shall be covered by the certification Risk Products Product Groups Services class? yes/no rule? Is a medicinal product according to Directive 2001/83/EC part of the product Yes No (medicinal product)? If yes, please specify: Is an animal tissue according to Commission Regulation (EU) No. 722/2012 part of the Yes No product? If yes, please specify:
Contact and Business Details Company Name Website Street No. ZIP code City Province Country Contact person Function Phone e-mail Certification according to (mark with “X”) Quality Management System ISO edition: 2012 2016 ☐ without development ☐ without development, production etc. ☐ MDSAP ☐ TCP (Taiwan) ☐ PAL (Japan) Medical Device Directive 93/42/EEC Annex II Annex II, Section 4 Annex III Annex V Annex VI Others ∙ Remarks Others ∙ Remarks (please specify) Information about your Company Precise description of the parts locations which shall be certified Please give a brief description of the activities of your company that should be covered by a certification process (e. g. design, production, distribution etc.) Are you already certified? Yes No Please attach a copy of your certificate(s)! Which parts and locations of your company should be certified? Name Address of the unit site location facility No. of people in the area of Total no. of people Shifts Design Administration Force Technical Field Service Production Other Full time Part time No. of shifts No. of people per shift Please attach a current organizational chart of your company! Products Services, which shall be covered by the certification Products Product Groups Services yes/no Risk class? rule? Is a medicinal product according to Directive 2001/83/EC part of the product (medicinal product)? Yes No If yes, please specify: Is an animal tissue according to Commission Regulation (EU) No. 722/2012 part of the product? Yes No If yes, please specify:
Questionnaire_Certification-QM%20ISO%2013485%20-%20MDD%2093-42-EEC.docx