Full range of domestic and international regulatory services

Domestic

• Audits: FDA QSR, pre-certification, pre-inspection, supplier, clinical research study
• Regulatory strategy development
• FDA Pre-Submissions, Q-Submissions, meeting coordination
• 513(g): Request for Classification
• FDA submissions: 510(k), IDE, PMA, De Novo
• Clinical Evaluation Reports, technical documentation, Declaration of Conformity
• Remediation activities (including 483 observations, warning letters, recalls)
• Post-market surveillance

International (Europe, Canada, Japan, Australia, South America)

• Audits: MDSAP, pre-certification, pre-inspection, supplier, clinical research study
• Regulatory strategy development
• EU MDR, IVDR: complete transition planning and execution
• CE mark submission
• Clinical Evaluation Reports, technical documentation, Declaration of Conformity
• Remediation activities (including audit findings, recalls)
• Post-market surveillance
• U.S. agent for foreign manufacturers

Internal

• Audits: Internal, pre-certification, pre-inspection, supplier, clinical research study
• Regulatory strategy development
• Compliance and/or remediation activities