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Prachi
@prachi_mehtaa
Turning Medical Device Regulations into Practical, Clear Solutions!
Inde
Anglais, Hindi
À propos de moi
I am a Certified ISO 13485:2016 Lead Auditor with 8+ years of experience in Quality Assurance & Regulatory Affairs for medical devices. I specialize in FDA 21 CFR Part 820, EU MDR, and ISO 14971:2019 compliance.
Services I offer:
- Design Control & DHF Documentation
- Risk Management (FMEA, Hazard Analysis)
- CAPA & Complaint Handling
- Process/Design Validation (IQ/OQ/PQ)
- Technical Writing (SOPs, Risk Management Plans)
- Regulatory Support (510(k), CE Marking)
I have worked with leading medtech companies to deliver audit-ready documentation and ensure smooth global regulatory approvals.
Compétences
Prachi
hors ligne •
Temps de réponse moyen de 1 heure
Voir mes services
Business
I will provide expert quality and regulatory consulting for medical devices
Évaluation des risques
I will be your qara medical device expert
