In 1978, U.S. FDA regulators chose Oriel STAT A MATRIX to work with the agency in rewriting the good manufacturing practice (GMP) regulations, the precursor to the current GMP (CGMP)/quality system regulations (QSR). We were then selected to train FDA compliance investigators in the new regulations.
Since then, we have been a global leader in assisting the medical device, pharmaceutical, and nutriceutical industries to implement quality and regulatory requirements. Our team includes former FDA regulators and other industry experts who have active, high-level knowledge of current and proposed FDA regulations and who can provide practical interpretations of both U.S. and European requirements.
Our FDA Compliance for Medical Devices practice touches every phase of the medical device life cycle: premarket, product realization, and postmarket.
Oriel STAT A MATRIX FDA Premarket Services
The successful development and application of processes and regulations in the premarket development phase is necessary to prevent potential lost revenue from postmarket consequences that could result in corrections, removals, or unforeseen regulatory enforcement actions.
Oriel STAT A MATRIX premarket services include:
- Providing support to product development planning and commercialization activities to help meet Strategic Business Objectives
- Developing a Quality “Master” Plan and Regulatory Strategy needed to achieve business, quality, and compliance success
- Serving in a liaison role with FDA and EU regulators, as well as their global counterparts, to facilitate premarket compliance
- Assessing product classifications and associated regulatory requirements in support of commercial initiatives
- Establishing science-based risk management throughout the “Total Product Life Cycle”
cGMP/Quality Management System Implementation Services
By developing a practical approach to defining, documenting, and implementing quality management systems, Oriel STAT A MATRIX helps customers stay in compliance. Our approach is focused on ease of implementation and on fostering self-sufficiency.
During this phase, in addition to the use of quality management principles, we take into account:
- Strategic management
- Resource management
- Life-cycle management
- System and process management
Some key subsystems involve:
- Management controls
- Design controls
- Production and process controls
- Labeling and packaging controls
- Facility and equipment controls
- Laboratory controls
- Material controls
- Purchasing controls
Oriel STAT A MATRIX FDA Industry Postmarket Services
Comprehensive postmarket support ensures that compliance is maintained and that performance goals are realized. Oriel STAT A MATRIX’s postmarket services focus on the measurement, analysis, and improvement of performance associated with:
- Measuring and monitoring product, process, and system performance
- Assessing process capability
- Achieving business, quality, and compliance objectives
- Satisfying the requirements of customers and other interested parties
Some key processes involve:
- Auditing product, process, and system, including outsourced processes and supplier management
- Complaint management
- Adverse event reporting
- Medical device reporting
- Risk analysis and health hazard evaluations
- Corrections and removals
- FDA 483 and FDA Warning Letter—crisis intervention and remediation
- Planning and preparing for managing FDA establishment inspections
We also provide support to organizations in selecting and implementing valid statistical methods and tools used for:
- Collecting and analyzing data
- Converting data into meaningful information
- Determining risk
- Investigating root cause
- Planning and implementing corrective and preventive actions
Learn more about FDA Compliance training and consulting