Services: Medical Device
QIS, Inc. provides support with a multi-disciplinary team widely experienced in all facets of the medical device industry. We facilitate knowing when and how to harmonize science, compliance, training and business goals to exactly offer value-added solutions for regulatory and quality needs. Solutions are customized to the stage and size of the company to provide essential foundations for product realization and market success.
QIS, Inc. offers a wide range of training that is tailored to the audience from executive management to engineers and is always customized to satisfy your specific learning needs.
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Quality Assurance
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Technical Support & Review
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QSR-GMP GAP Analysis
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Design and development planning
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Due Diligence Audits
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Design verification and validation
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Mock Inspection Audits
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Engineering Reports
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DHF and DMR Gap Analysis
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DHF and DMR support
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Remediation Support Services
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Design and Manufacturing records
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SOP development and compliance support
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Process Validation
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QSR subsystems compliance support
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Quality Control records
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ISO 13485 compliance support
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Risk Management
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In-Vitro Diagnostic compliance support
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Training
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Supplier Vendor Programs
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QSR Overview
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CAPA
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Design Controls
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Training Program Implementation support
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The Regulatory Submission Process and types of 510(k)’s
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Quality Control Implementation support
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How to classify your product
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Regulatory Affairs
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How does a Small Company get started with QSR compliance
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510(k)
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What documents are needed in a 510(k) submission
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PMA
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Good Documentation and Recordkeeping Practices
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IDE
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Hosting an FDA Inspection
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Design Dossiers/Technical File
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When to submit a 510(k) for a new or changed product.
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FD-483 and Warning Letter remediation activities
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User Fees and Establishment Registration
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Risk Management
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Most common 510(k) delays and how to prevent them
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Most Common 483 and Warning Letter Trends For This Year
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