Mary Dadone & Associates
Global Regulatory Affairs and Quality Assurance Expertise
for the Medical Device Industry
Regulatory and Quality support as you need it, when you need it
Regulatory Submissions
Regulatory Strategy
Supplemental
Regulatory Expertise
and Assistance
- Master Files
- Pre-submission Meetings
- 510(k)s / PMAs / Annual Reports
- Investigational Device Exemptions (IDEs)
- 513(g) Requests / De Novo Classification
- CE Mark Technical Files / Design Dossiers
- Match Your Regulatory Strategy to Your Business Plans
- Address Regulatory Requirements as Part of the Design Requirements
- Ensure Professional Regulatory Due Diligence for Investments, Mergers, and Acquisitions
- Define, Understand, and Manage Cost and Schedule Risk through Understanding the Regulatory Options and Risks
- Contract-Based Regulatory Leadership
- Major Projects That Exceed In-House Resource Capabilities
- Part time, as-needed Regulatory Expertise for Small Companies
- As-Needed Team Members for Product Development Projects
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Quality System Development and Remediation
Quality Audits
Due Diligence
- Supplier Audits
- Independent Audits
- Audit Preparation and Support
- Audit Responses
- Regulatory Risk Assessments
- Regulatory Realism
- Quality System Assessments and Risk Analysis
- Review of Global Regulatory Status, Complaint Files, Regulatory Notifications, and Regulatory Actions
- Quality System Development from the Ground Up
- Quality Manuals and Quality Plans
- New Facility and Facility Relocation Plans
- Expert Assistance with Audit Findings and 483’s
- Manage 483s, Warning Letters, and Consent Decrees
- Template SOPs for 21CFR820 and ISO 13485 Compliance
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Document Reviews
Adverse Event Reporting, Recalls, and Notifications
Regulatory Representation
- Label and Labelling Reviews
- Design History File and Device Master Record Reviews and Audits
- Risk Management File Reviews
- CAPA File Reviews
- Complaint File Reviews
- Technical File Reviews and Audits
- Official Correspondent and FDA Agent for Medical Device Establishments Outside the US
- FDA Establishment Registration and Device Listing
- Complaint Investigations
- Recall/Field Action Planning and Coordination
- Review of Complaint and Adverse Event Records
- Global Adverse Event Reporting and Notifications
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