1 Regulatory consulting for the Medical Devices (non IVD) industry:
- CE marking of conformity
- Supporting development process for regulatory compliance
- Supporting and advising readiness for compliance with new MDR
- Act as RA responsible person for ECREP organisations
- EMEA / APAC submissions
- Technical file / Design Dossier writing and assembly, according to STED / CSDT format
- Clinical studies for compliance with MDR
All risk classes supported, including AIMD
2 Supplier and distributor audits (worldwide) for compliance with ISO 13485, issues 2003, 2012 and 2016