Please inform us about the categorization of your medical devices in subcategories (class IIa) and/or generic device groups (class IIb) as per directive 2007/47/EC in the attachment to questions for quoting. Do you sell products under your own company name, which are produced yes no by other companies (OEM PLM)? – If yes, did the original equipment manufacturer (OEM) already carry out a yes no conformity assessment procedure? If yes: is the complete technical documentation available? yes no If it is not available: does a report by a notified body exist? yes no Do any quality management system (QMS) certificates for your company yes no already 3. Desired conformity assessment procedure (please refer to page 5 of the attachment) MDD IVDD AIMDD QMS (93/42/EEC) (98/79/EC) (90/385/EEC) certificates EC Directive on EC Directive on EC Directive on active medical devices In vitro diagnostics implantable medical devices II (without II.4) Annex III.6 Annex 2 No certificate Annex II.4 Annex IV.3 EN ISO 9001 Annex III + IV Annex IV.3 + IV.4 + IV.6 EN ISO Annex III + V Annex V + VI ISO Annex III + VI Annex V + VII ISO 13485 under CMDCAS IV Annex V + VII.3 + VII.5 Annex V Annex VI Further international approvals: FDA Mock audit TCP Taiwan Do you wish a Pre-audit yes no (Recommended in case of certification for the first time)? In which language can audits be carried out? German English In which language is your QM system described? German English In which language is your technical documentation written? German English 4. Details about your quality management system Please specify the scope of your quality management system < Example for scope: Design and development, (QMS), as stated in your quality manual: manufacture and distribution of dental implants > Production Activities excluded from the scope of the QMS: (Please mark if applicable) Design and development Did you receive consultancy regarding the implementation of yes, by: your QMS? no
Please inform us about the categorization of your medical devices in subcategories (class IIa) and/or generic device groups (class IIb) as per directive 2007/47/EC in the attachment to questions for quoting. Do you sell products under your own company name, which are produced by other companies (OEM – PLM)? yes no If yes, did the original equipment manufacturer (OEM) already carry out a conformity assessment procedure? yes no If yes: is the complete technical documentation available? If it is not available: does a report by a notified body exist? yes no yes no Do any quality management system (QMS) certificates for your company already yes no 3. Desired conformity assessment procedure (please refer to page 5 of the attachment) MDD (93/42/EEC) EC Directive on medical devices IVDD (98/79/EC) EC Directive on In vitro diagnostics AIMDD (90/385/EEC) EC Directive on active implantable medical devices QMS certificates II (without II.4) Annex III.6 Annex 2 No certificate Annex II.4 Annex IV.3 EN ISO 9001 Annex III + IV Annex IV.3 + IV.4 + IV.6 EN ISO Annex III + V Annex V + VI ISO Annex III + VI IV Annex V Annex VI Annex V + VII Annex V + VII.3 + VII.5 ISO 13485 under CMDCAS Further international approvals: FDA Mock audit TCP Taiwan Do you wish a Pre-audit (Recommended in case of certification for the first time)? yes no In which language can audits be carried out? German English In which language is your QM system described? German English In which language is your technical documentation written? German English 4. Details about your quality management system Please specify the scope of your quality management system (QMS), as stated in your quality manual: < Example for scope: Design and development, manufacture and distribution of dental implants > Activities excluded from the scope of the QMS: (Please mark if applicable) Production Design and development Did you receive consultancy regarding the implementation of your QMS? yes, by: no
Questions_for_quoting_Rev.0.docx