Information on certification DQS MED certifications Please choose the desired or existing DQS MED certifications by entering crosses in the right column Activities (examples) Certification standard or regulation “X“ Medical device manufacturer QMS requirements, DAkkS accredited EN ISO 13485 / DIN EN ISO 13485 / ISO 13485 ☐ Medical device manufacturer QMS requirements, SCC accredited ISO 13485 ☐ General QMS requirements ISO 9001 (Caution: additional cost to ISO 13485) ☐ Manufacturer of primary packaging for pharmaceuticals ISO 15378 ☐ Medical device manufacturer for the EU/EWR/CH, CE certification Directive 93/42/EEC Procedure according to Annex II without No. 4 Class I (sterile/with measuring function), Class IIa, Class IIb ☐ Procedure according to Annex V Class I (sterile/with measuring function), Class IIa ☐ Procedure according to Annex VI Class IIa (only active medical devices) ☐ Annex II with No. 4 (EC Design Examination) Class III ☐ Other please specify: ☐ -required for ISO 13485- Use the form 410.141 Basic Data List of Medical Devices List of Product/Services – Table Products and services ISO 13485 DQS MED requires an up-to-date list of products and services covered by certification for all medical device certifications Please also mind No. 3.4 for Directive 93/42/EEC. Attached, dated: Klicken Sie hier, um ein Datum einzugeben. ☐ Enter here the revision date of the attached list.
Information on certification DQS MED certifications Please choose the desired or existing DQS MED certifications by entering crosses in the right column Activities (examples) Certification standard or regulation “X“ Medical device manufacturer QMS requirements, DAkkS accredited EN ISO 13485 / DIN EN ISO 13485 / ISO 13485 ☐ Medical device manufacturer QMS requirements, SCC accredited ISO 13485 ☐ General QMS requirements ISO 9001 (Caution: additional cost to ISO 13485) ☐ Manufacturer of primary packaging for pharmaceuticals ISO 15378 ☐ Medical device manufacturer for the EU/EWR/CH, CE certification Directive 93/42/EEC Class I (sterile/with measuring function), Class IIa, Class IIb Procedure according to Annex II without No. 4 ☐ Class I (sterile/with measuring function), Class IIa Procedure according to Annex V ☐ Class IIa (only active medical devices) Procedure according to Annex VI ☐ Class III Annex II with No. 4 (EC Design Examination) ☐ Other please specify: ☐ List of Product/Services -required for ISO 13485- DQS MED requires an up-to-date list of products and services covered by certification for all medical device certifications ☐ Attached, dated: Klicken Sie hier, um ein Datum einzugeben. Use the form 410.141 Basic Data – List of Medical Devices Table Products and services ISO 13485 Please also mind No. 3.4 for Directive 93/42/EEC. Enter here the revision date of the attached list.
410_14e_Basic_Data_Organisation_MD.docx