START YOUR APPLICATION PROCESS
Send us your initial enquiry for conformity assessment. We accept technical documentation in English and German under Regulations (EU) 2017/746 and (EU) 2017/745. Please note that only fully completed forms can be processed.
What You Will Need
Information Requested in the Form
Contact & Company Details
Contact person, email and phone; company name, billing email, address, website, VAT number and Single Registration Number (SRN).
Services Required
MDR conformity assessment, IVDR conformity assessment, system certification (ISO 13485) or other services.
Device Classification
MDR classes Ir/Is/Im, IIa, IIb, III or IVDR classes As, B, C, D, with device counts, sterilisation methods, software or AI use and applicable codes.
Quality Management System
Number of full-time employees, up to five additional sites with FTEs and their role (production or design), existing certifications, transfer and legacy device status.
Documentation & Preferences
Preferred language (English or German), when your documentation will be ready and your IAF MD9 activity areas.
Consents
Acceptance of the terms and your choice on marketing communications.
Questions Before You Apply?
Call our team and we will guide you through the form.
