Services

Quality Systems

Quality Management System audits, implementation, gap analyses, improvement, and ongoing maintenance for compliance to:

• European Union Medical Devices Regulation (EU MDR – 2017/745)
• FDA Regulation (21 CFR 820, 21 CFR 1271, and related regulations)
• ISO 13485:2016

Resolution of:

• FDA Warning Letters, FDA 483s, Notified Body audit reports, or other authority findings.
• Corrective Action Preventative Action (CAPA) reports
• Non-Conformance Reports (NCR) findings

Clinical & Case Management

• Clinical Research Liaison (in accordance with GCP/ICH guidelines)
• Clinical Research Consulting (full services and staff available upon request)
• RN Case Management
• Remote training/auditing for:
  • Risk Management
  • Good Manufacturing Practices
  • Quality Management Systems
  • Complaint sample evaluation (In-house per client request)
  • Manufacturing
  • Lab/Pilot Lab/Biohazard Lab
• Post Market Surveillance
• Literature analysis review
• Internal Audits
• Manufacturing Lot Release