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QMS Consultancy Services
Pharma wizard Quality Management System (QMS) consultancy services help medical device manufacturers establish and maintain systems that meet global Regulatory standards. These services ensure product quality, patient safety, and compliance with regulations like-
- ISO 13485:2016
- US FDA 21 CFR 820
- Medical Device Single Audit Program (MDSAP)
- Korea Good Manufacturing Practice (KGMP)
- Brazilian Good Manufacturing Practice (BGMP)
- DRAP MDR 2017
- Quality System Documentation (QSD), Taiwan
- Ministry of Health, Labor and Welfare (MHLW), Japan MO169
Our Core Services Include:
- QMS Design & Implementation
- Regulatory Compliance Support
- Audit & Gap Assessments
- Risk Management
- Training & Education
Pharma wizard QMS Consultancy Services
ISO 13485 Certification
ISO 13485 certification services for your medical devices.
MDSAP
Tailored MDSAP compliance support as per your regulatory needs.
FDA 21 CFR Part 820 Quality System Regulation (QSR)
Quality System Regulation (QSR)
ISO 14971 Risk Management Consulting
Meet global Regulatory standards with Pharma Wizard ISO 14971 Risk Management Services.