• Laboratory Developed Tests (LDT) and In Vitro Devices (IVDs) regulatory and quality support, strategies and submissions
• IVDR Consulting, Support and Submissions
• Medical Devices Consulting, QMS Development/Implementation, GAP Assessment
• Risk Management (ISO14971)
• Regulatory Support and Submissions
• EU MDR, IVDR and ISO13485 GAP Assessment
• Post Market Surveillance
• Technical Files, CE marking
• CTAs, IDEs, Q -Submissions, 510K Submissions