Image by Damiano Lingauri

Quality Assurance

When you make quality a habit, you quality into your product and company from day one.

QMS Development

  • Quality Plan, SOPs, and Forms

  • Full Quality Management System (QMS) Development

  • QMS Training

QMS Alignment

  • Combination Products

  • Post M&A

QMS Record Remediation

  • Corrective and Preventive Actions (CAPA)

  • Complaints

  • Design History File (DHF)

Audit Support

  • QMS Audits

  • Gap Assessment

  • Pre-Approval Inspection

  • Verification Audit

  • Certification Preparation Audit

  • Mock FDA Inspection

  • MSDAP Preparation

  • ISO 13485 Audit Preparation

  • Supplier Audit

  • Due Diligence Audit

QMS Maintenance

  • CAPAs

  • Complaint Handling

  • Adverse Event Reporting

     

R&D Support

  • Quality Control (QC) Support During Product Development

  • QC Manufacturing Support & Training