At DeSia, we guide medical and IVD device manufacturers through complex regulatory and quality requirements. Our services ensure your products meet MDR, IVDR, FDA, and international standards.
What We Offer
- Quality management system setup and improvement (ISO 13485)
- Regulatory strategy and device classification
- Technical file preparation and review (MDR/IVDR)
- Risk analysis and documentation (ISO 14971)
- Post marketing surveillance planning and reporting (PMS, PSUR)
- Internal, supplier, MDSAP mock/gap audits
- CE and FDA submission support
Do you need support with your regulatory and quality system? Book your complimentary initial consultation.
