THE FOLLOWING ARE OUR AREAS OF EXPERTISE
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End-to-End Medical Device Design Controls
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Risk Management
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Change Management
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Process Validation
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Test Method Validation
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Supplier Qualification & PPAP
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Audit Support
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ISO 13485 Certification
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Company wide QMS Implementation
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US FDA Submission
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EU MDR CE Submission & Techfile Preparation
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SDLC IEC 62304
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Indian Medical Device Rules
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CDSCO Certifications & Licenses