In 1977, FDA chose Oriel STAT A MATRIX to work with the agency to train their investigators in the new draft Good Manufacturing Practice (GMP) regulations, the precursor to the current cGMP/Quality System Regulations (QSR). Since then we've been helping life science organizations to integrate compliance activities with performance improvement processes throughout the product life cycle, from initial concept, development, and commercialization through postmarket management.
Our goal: to establish systems that not only comply with regulations but also continually improve business processes.
Our medical device experts can help your company:
Develop a compliant quality system:
Get your product to market
- Plan and prepare presubmission and product approval documentation, including:
Manage your quality system and sustain compliance
- Implement an effective corrective and preventive action (CAPA) process.
- Conduct internal and supplier audits.
- Establish a complaint-handling and safety-reporting process.
- Manage your supply base.
Respond to enforcement actions
Improve performance without compromising regulatory compliance
Medical device RA/QA training
Find medical device regulatory compliance training courses for beginners through experts. Oriel STAT A MATRIX offers hundreds of classes on FDA regulatory compliance and medical device-related topics in dozens of cities around the United States and in Costa Rica, as well as Professional Certificate Programs.
We can customize any course for your company and bring it to a location of your choice. For groups of five or more, these on-site classes are a cost-effective, flexible way to train your employees.
Questions? Please contact us to find out more about our medical device RA/QA services.