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 services that are tailored to the audience from executive management to engineers and is always customized to satisfy your specific compliance needs.
Quality Assurance
- QSR-GMP Gap Analysis
- Due Diligence Audits
- Mock Inspection Audits
- DHF and DMR Gap Analysis
- Remediation Support Services
- SOP development and compliance support
- QSR subsystems compliance support
- ISO 13485 compliance support
- In-Vitro Diagnostic compliance support
- Supplier Vendor Programs
- CAPA
- Training Program Implementation support
- Quality Control Implementation support
Regulatory Affairs
- 510(k)
- PMA
- IDE
- Design Dossiers/Technical File
- FD-483 and Warning Letter Remediation activities
Technical Support and Review
- Design and development planning
- Design verification and validation
- Engineering Reports
- DHF and DMR support
- Design and Manufacturing records
- Process Validation
- Quality Control records
- Risk Management
Training
- QSR Overview
- Design Controls
- The Regulatory Submission Process and types of 510(k)’s
- How to classify your product
- How does a Small Company get started with QSR compliance
- What documents are needed in a 510(k) submission
- Good Documentation and Record Keeping Practices
- Hosting an FDA Inspection
- When to submit a 510(k) for a new or changed product
- User Fees and Establishment Registration
- Risk Management
- Most common 510(k) delays and how to prevent them
- Most common 483 and Warning Letter Trends for this year
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