Regulatory Submissions

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​

Regulatory Strategy

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​

Supplemental Regulatory Expertise

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

Quality System Development

and Remediation 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​

Quality Audits

Supplier Audits Independent Audits Audit Preparation and Support Audit Responses

Document Reviews

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

Adverse Event Reporting, Recalls,

and Notifications Complaint Investigations Recall/Field Action Planning and Coordination Review of Complaint and Adverse Event Records Global Adverse Event Reporting and Notifications

Regulatory Representation

Official Correspondent and FDA Agent for Medical Device Establishments Outside the US FDA Establishment Registration and Device Listing

Due Diligence

Regulatory Risk Assessments Regulatory Realism Quality System Assessments and Risk Analysis Review of Global Regulatory Status, Complaint Files, Regulatory Notifications, and Regulatory Actions