QUALITY MANAGEMENT SYSTEM
ISO 13485 and 21 CFR Part 820
Medical Device Single Audit Program (MDSAP)
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Gap Analysis
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Implementation Plan
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Document Control and Records Management
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Quality Audits
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Management Review
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CAPA Management
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Validation Services​
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Design Control Services
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Complaint Handling and Adverse Event Reporting​
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Supplier Management and Evaluation
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Employee Training​
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Quality Metrics and Monitoring​
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FDA Inspection and Notified Body Audit Readiness​
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Regulatory Submission Support​
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Post-Market Surveillance and Risk Management​
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Full Support for External ISO 13485 Certification
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At Panabistics, we offer a holistic approach to quality management compliance, covering all key areas of both ISO 13485 and 21 CFR Part 820. We are committed to ensuring your successful certification and ongoing compliance.
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MDSAP Gap Analysis
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MDSAP Readiness Assessment​
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Audit Support
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Quality Audit Preparation​
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Training Services
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Document and Record Management
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Regulatory Alignment
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Adverse Event Reporting​
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Supplier Management
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Post-Market Surveillance Support​
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Data Management and Metrics​
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Quality Planning
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CAPA Implementation and Monitoring:
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Risk Management​
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Regulatory Consultation
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License Maintenance​
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Our comprehensive MDSAP services at Panabistics ensure that your medical device company not only achieves but maintains compliance with this multinational program. We provide end-to-end support, from initial gap analysis to ongoing post-market surveillance, giving you the peace of mind to focus on what you do best: developing life-changing medical devices.
Elevate Compliance with Panabistics: Your QMS Partner