Our Quality Assurance Team enforces regulations to produce safe and effective medical devices
The Quality Assurance (Q.A.) and Regulatory Affairs team has a critical effect in the level of satisfaction, effectiveness and safety of the medical devices that we provide to our patients and customers. It is important to keep in mind the new task of the FDA’s personnel to inspect and investigate facilities and audit the level of commitment and the quality output of the products sold.
The benefits that patients and physicians experience as a result of the efforts contributed by our Quality Assurance Team are:
- Medical devices manufactured, monitored, inspected, tested, documented, validated, meeting and exceeding strict FDA’s regulations and standards therefore our precuts are capable of competing with global medical devices companies.
- Our Corrective and Preventive Action as well as our Complaint system have been commended by FDA’s and CHAP’s auditors.
- Patients praise our medical devices because they are reliable, safe and cost competitive.
VQ OrthoCare is committed to comply with the FDA’s rules and regulations at all times and cost; we passed our last audit by the FDA with no findings. We recently passed CHAP’s audit and will be recommended for certification for the next three years.
The Q.A. team is personally involved with the qualification process of our suppliers, monitors their performance at all times, makes recommendations to improve quality, approves the acceptance of critical medical devices and components, has implemented the Quality System processes and procedures as they are used throughout VQ OrthoCare; audits the patients’ files to make sure they are in compliance with the fraud and abuse regulations in addition to requirements established by Medicare, Advamed, etc.
—VP, Quality Assurance/Regulatory Affairs