FDA and Internationally Regulated Medical Devices Consulting Services

STAT-A-MATRIX provides directed consulting services for FDA-regulated companies in areas such as design control; document review, process validation; software verification and validation; risk assessment and analysis; audit preparation, CE marking; and responses to FDA findings. STAT-A-MATRIX clients have included major medical device and diagnostic companies as well as start-ups. Our staff includes experienced industry experts, as well as former FDA professionals who are able to assist knowledgeable professionals as well as beginners. Our technical support services are a cost-effective extension of your in-house capabilities.

We customize the appropriate training, evaluation, planning, and consulting to support all phases of your organization's compliance with FDA's current Good Manufacturing Practice for Medical Devices (21 CFR 820), the Quality System Regulation (QSR).

Since the intent of this standard is to harmonize U.S. codes with ISO 9001 and ISO 13485, our program considers national and international standards, guidelines, and their interrelationships.

FDA Compliance

• 510(k)/Premarket Notification Submission Services
• Corrective and Preventive Action (CAPA)
• Design Control
• FDA GMP Quality System Auditing and Supplier Audits
• ISO 14971 Risk Management Consulting
• Process, Equipment, and Software Validation
• Quality System Implementation and Compliance with CGMP
• Mock FDA Audits
• Regulatory strategy development

ISO Compliance

• ISO 13485 Quality System Auditing and Supplier Audits
• Quality System Implementation and Registration for ISO 13485

Crisis Intervention

• FDA Form 483 and Warning Letters

European Compliance

• CE Marking, Medical Device Directive (MDD), In Vitro Diagnostic Directive (IVDD)

STAT-A-MATRIX clients have included major medical device and diagnostics companies as well as start-ups. Our staff includes experienced industry experts who are able to assist knowledgeable professionals as well as beginners.

For more information on Medical Device offerings, click below