


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)
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