Challenge
A European manufacturer of nasal hygiene Medical Device received Notified Body observations requiring robust assessments for CMR, endocrine disruptors (ED), phthalates, and extractables & leachables (E&L). Additionally, MACO-based cleaning validation justification across multiple manufacturing sites was required to meet MDR expectations.
Approach
SciQra delivered a comprehensive, regulator-aligned program:
Developed CMR, ED, and phthalate risk assessments
Conducted toxicological risk assessment of extractables & leachables per ISO 10993-17/18
Reviewed and strengthened existing technical documentation
Established PDE-based MACO calculations and justified cleaning validation criteria across sites
Outcome
Successfully addressed Notified Body observations
Achieved MDR compliance without deficiencies
Enabled product readiness for multi-region commercialization with validated safety
Impact
- 100% Notified Body acceptance
Significant reduction in approval timelines
Transformation
Before: Notified Body observations and gaps in CMR, E&L, and cleaning validation justification
After: Fully compliant MDR dossier with validated safety assessments and successful regulatory clearance
From regulatory gaps to approval - driven by science and precision.