"The validation of the CEA and ultrapure water system were thoroughly planned and well-executed in accordance with best industry practices and current standards."
-Director, Quality Assurance
A robust quality system is integral to ongoing regulatory compliance and smooth inspections and audits. QA Consulting is fully equipped to serve as an outsourced quality department, creating and implementing a customized quality system for our clients.
Our extensive experience in quality systems includes the following:
- Quality Management System Development & Implementation
We identify necessary procedures based on client and product-specific needs and develop and deploy customized standard operating procedures (SOPs).
- Design Control
We offer design control solutions from concept through design transfer. Our Consultants guide our clients through each phase of the process to establish and maintain design history files (DHF).
- Risk Management
A risk management strategy is essential when developing and manufacturing medical devices and a well-cultivated risk plan must be integrated throughout the product lifecycle. QA Consulting has developed solutions to address the BS EN ISO 14971:2012 requirements for risk planning, risk management, and to reduce risk as far as possible for each client. We work with each client’s unique needs to customize traditional analysis methods such as fault tree analysis (FTA) and failure mode effect criticality analysis (FMECA) for the situation.
- Post Production Services
- Nonconforming Material Reports
- Complaint Handling
- Medical Device Reporting (MDR)
- Corrective Actions and Preventive Actions (CAPA)
- Management Review
- Health Hazard Evaluations (HHE)
- 483 and Warning Letter Responses
- Design Verification and Validation
Our Consultants determine test requirements, select and manage appropriate laboratory service providers, generate protocols and reports, analyze data, and resolve failures.
- Project Management
We assign a project manager as the single point of contact for each project. Our project managers and consultants have the skills and experience to manage both long and complex projects as well as projects of shorter duration at whatever level the client requests. We utilize a team-based approach to select the most appropriate expert for each project deliverable, resulting in added value for our clients.
- Unique Device Identification (UDI)
Our consultants develop an implementation strategy customized for each client’s products and supply chain structure. This includes obtaining UDIs, creating and validating UDI labels/direct part marking, and managing the Global UDI Database (GUDID) submission to the FDA.
- Quality System Training
Training is matched to each client’s needs for integration of quality-related practices into their organization.
- Virtual Document Control
We develop organized and functional document control and record management systems for effective and traceable implementation of quality systems.
* If you do not see your specific quality need listed above, please call us for a more detailed list of services at 512.328.9404