Quality Management
- ISO 13485 : Full processes establishment, Post-Marketing Surveillance.
- GMP & Pharma : Support for CTD Module 1-4 writing and submission.
- Risk management ISO 14971 : Risk management process, Risk management reports, FMEA.
- Auditing (ISO 19011) : Internal and external audits.
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Regulatory Affairs
- CE Marking submissions (MDR & legacy MDD) : Conformity to MDR Regulation 2017/745: Technical files, Design History Files, GSPR.
- US FDA submissions (21 CFR 820) : PMA, 510(k)
- Labeling: Eudamed/Swissdamed registrations, updates, follow-up. ISO 20417 & ISO 15223 labeling conformity.
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