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.

The STAT-A-MATRIX (SAM) quality performance assessment service was designed to provide an independent opinion regarding the effectiveness and efficiency of an organization in managing its processes and the maturity of its quality management system.

The performance assessment results can be used by an organization to ensure that the requirements of all interested parties are fulfilled and to determine where to invest in resources to achieve improvements that will mitigate risks. Learn more about the STAT-A-MATRIX Quality Performance Assessment.

The STAT-A-MATRIX 14-step implementation process is applicable to companies seeking compliance with the FDA's Medical Device Quality System Regulation, and applicable as well to ISO 13485 registration. Since ISO has adopted a process approach model that pursues continual improvement and customer satisfaction, the business benefits of implementing Lean Six Sigma processes are now clearly aligned with the regulatory imperative of prevention of defects. Learn more about the STAT-A-MATRIX 14-step implementation process.

How can you ensure that your organization is compliant with regulatory issues? STAT-A-MATRIX provides regulatory consulting and technical services support for companies seeking guidance and understanding of national and international codes, directives, regulations, and standards as they apply to medical devices. Our team has active, expert knowledge of current and proposed regulations and provides practical interpretations of both U.S. and European requirements.

FDA Compliance

• Regulatory strategy development
• 510(k)/PMA submission services
• Process validation
• Compliance with CGMPs
• On-site audits
• Quality system implementation
• Clinical trial development/management

ISO Compliance

• ISO 9001:2000
• ISO 13485:2003

Crisis Intervention

• FDA inspectional observations (483s)
• Warning letters
• Product recalls

European Compliance

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

Other Industry-Regulated Services

• HACCP
• In vitro diagnostic research and development

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.