Quotation for certification

For Certification (QM-Standards)

Questionnaire for a Quotation (QM-Standards ISO 13485, ISO 9001)

For manufacturers of medical devices (notified body required)

Questionnaire according to Regulation 2017/745 (MDR) and, if applicable, QM-Standards (ISO 13485, ISO 9001)

Attachments:

Annex I List of medical devices

Annex II Questionnaire Medical devices class Ir (if applicable)
 

For manufacturers of in-vitro diagnostics (notified body required)

Questionnaire according to Regulation 2017/746 and if applicable QM-Standards (ISO 13485, ISO 9001)
 

Attachments:

List of In Vitro Diagnostic Medical Devices (IVDR)

For pharmaceutical manufacturers

Questionnaire according to article 117 of Regulation 2017/745 (MDR)
 

For certifications according to MDSAP (Medical Device Single Audit Program)

Questionnaire from our cooperation partner: Basic Data of MDSAP

Guideline: Guidance Basic Data of MDSAP