Improve performance, achieve regulatory compliance, and secure sustainable success.
Oriel STAT A MATRIX is a global consultancy and training firm focused on medical device regulatory compliance, product development planning, quality management, Lean and Six Sigma, regulatory support, strategy planning, and training.
Service, manufacturing, healthcare, and governmental clients rely on our broad subject matter expertise, experience supporting industry leaders, and ability to deliver results that matter.
Our goal: Help our clients boost efficiency, decrease costs, and improve
Oriel STAT A MATRIX:
- Specializes in FDA and international regulatory compliance, quality management systems, product submissions, and performance improvement. We have the industry expertise you need to get high-quality products to market.
- Fuses regulatory expertise with an established performance excellence practice. Our fluency in both regulatory requirements and improvement methodologies allows our customers to boost performance while safeguarding their regulatory compliance.
- Provides specific technical assistance for product submissions, including 510(k), PMA, GMP audits, and US Agent services. No matter what type of device your organization produces, we can help you get it to market.
- Offers an experienced team consisting of former FDA compliance and inspection officials and industry executives, assisted by an international network of consultants with decades of experience.
- Serves organizations around the world. Headquartered in Edison, New Jersey, Oriel STAT A MATRIX’s consultants and auditors are found in strategic locations throughout the US, Europe, Latin America, and Asia.
Our Commitment to Our Customers:
- We listen to your needs and deliver practical solutions that make sense for your business.
- We create self-sustaining programs by transferring knowledge and skills to your organization.
- We maintain high standards for service and support.
- We meet and exceed your expectations.