Quality Assurance
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Quality Systems evaluations & gap-analysis
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Software Validation
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Unique Device Identification (UDI) – for CE & FDA
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Developing and implementing QMS plans & strategies:
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ISO 13485 compliance & certification
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RISK Based APPROACH
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CLOSED-LOOP TRACEABILITY(CLT)
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CAPA System Management
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Change Control Management
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MRB handling
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Complains handling
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MDSAP Audits compliance (for USFDA, Canada, Japan, Australia, Brazil)
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