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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)



Annex I List of medical devices

Annex II Questionnaire Medical devices class Ir (if applicable)


For manufacturers of in-vitro diagnostics

Questionnaire according to 98/79/EC (IVDD) + QM standards


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