Clinical, Regulatory and Quality Systems Strategists
- Clinical Study Plans
- Study Design and Protocol Development
- Study Management
- High and Moderate Complexity Devices
- Point of Care Devices
- Over the Counter and At-home Devices
- Usability Studies
- Reproducibility Studies
- Study Reports
- Data Management Plans
- Statistical Analysis Reports
- EDC Support
- Data Analysis and Visualization
- Regulatory Strategy
- Regulatory Submissions
- Breakthrough Device Designation
- STeP Program
- Pre-submission
- Pre-submission Supplement
- 510(k)
- De Novo
- PMA
- FDA Registration and Listing
- US Agent Representation
- IVDR Gap Analysis
- Technical File Support
- QMS/eQMS Strategy and Implementation
- eQMS Platform Selection
- IVDR QMS Compliance
- Certifications ISO 13485, ISO 9001, ISO 1705, MDSAP, IVDR
- Registrar and Notified Body Selection
- Internal Quality Audit Management (IQA)
- CAPA Management and Audit Remediation
- FDA Warning Letter Support and Remediation
- Product Recalls and Withdrawal
- CLIA Lab QMS Accreditation
- Clinical Site Network
- Specimen Sourcing
- Market Research
- Market Access
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Key Opinion Leaders
- Software Review and Submission Guidance
- Analytical Study Support
- CLIA Lab Setup
