IQZYME provides the following support to customer for compliance with EU Directives and for obtaining / affixing CE Marking.
- Identification of applicable directives
- Finalization of Conformity assessment procedures
- Identification of applicable harmonized standards
- Ensure the compliance with essential principles
- European Representative (EC-REP)
- Technical Files in compliance with requirements of Directives 93/42/EEC, 90/385/EEC, 98/79/EC, REGULATION (EU) 2017/745 (MDR), REGULATION (EU) 2017/746 (IVDR)
