MEDICAL DEVICES & IVD
EU MDR & IVDR REGULATORY AND QUALITY SUPPORT
PHA FARMED supports medical device and IVD companies in navigating EU MDR and IVDR requirements throughout product development, conformity assessment and market entry.
Our experts provide regulatory, quality and operational support tailored to the device, risk classification and specific requirements of each project.
REGULATORY STRATEGY & TECHNICAL DOCUMENTATION
Regulatory support from initial classification through conformity assessment and market entry.
- MDR & IVDR regulatory strategy
- Device classification
- Technical documentation review and preparation
- Conformity assessment pathway
- Notified Body coordination
- CE-marking support
QMS & COMPLIANCE
Quality and compliance support aligned with applicable medical device requirements and standards.
- ISO 13485 QMS implementation and support
- Gap assessments
- SOPs and quality documentation
- Audit and inspection readiness
- CAPA support
- Supplier and partner qualification
EUDAMED, UDI & POST-MARKET SUPPORT
Practical support with registration, traceability and post-market regulatory requirements.
- EUDAMED registration support
- UDI implementation
- Economic operator requirements
- Post-market surveillance (PMS) support
- PMCF / PMPF support, where applicable
- Vigilance coordination
- Lifecycle regulatory support
Need support with EU MDR or IVDR compliance?
Let’s discuss the regulatory and quality pathway for your medical device or IVD.