We TRACC Global are your go to medical device solution.Our commitment to excellence extends beyond product development. Collaboration is at the core of our ethos.
TRACC Global offers a range of services to support companies in developing and maintaining their Quality Management Systems (QMS) and addressing the complexities of risk management. Here are some key areas where TRACC Global can assist-
TRACC Global conducts thorough gap assessments of your current QMS to identify any deficiencies or areas of non-compliance. Based on the assessment findings, the team provides remediation support to address the gaps and ensure regulatory compliance.
TRACC Global leverages its decade of experience and expertise to build customized QMS tailored to the specific needs of your company. Whether you require a QMS built from scratch or a makeover of your existing system, TRACC Global can help you establish a robust and efficient quality management framework.
TRACC Global assists in developing a comprehensive Quality Manual aligned with your company's objectives and mission. Additionally, the team can help prepare the Site Master File, which provides a detailed overview of your manufacturing site and its operations. Standard Procedure Preparation and Review: TRACC Global supports the preparation and review of standard operating procedures (SOPs) to ensure they are aligned with regulatory requirements and industry best practices. This helps establish consistent processes and documentation within your organization.
TRACC Global offers manufacturing compliance oversight to ensure adherence to regulatory requirements and quality standards. This includes assessing manufacturing processes, implementing quality controls, and conducting audits to maintain compliance. Complaint Management: TRACC Global assists in establishing an effective complaint management system, enabling you to capture, evaluate, and address customer complaints in a timely and compliant manner. This helps improve product quality and customer satisfaction
TRACC Global works with your company to develop a comprehensive risk management platform for your products and processes. This includes creating Risk Management Plans, Risk Management Reports, conducting hazard analysis, and performing Failure Mode and Effects Analysis (FMEA) in accordance with ISO 14971:2019. The goal is to identify, assess, and mitigate risks associated with your medical devices.
TRACC Global provides guidance on data integrity practices and helps implement measures to ensure the integrity, accuracy, and security of data generated throughout your quality management processes.
TRACC Global assists in establishing an effective complaint management system, enabling you to capture, evaluate, and address customer complaints in a timely and compliant manner. This helps improve product quality and customer satisfaction.
TRACC Global conducts awareness trainings to educate your team on quality management principles, regulatory requirements, and best practices. These trainings help foster a culture of quality and compliance within your organization. Whether you require support on a project basis or a long-term contract, TRACC Global is committed to helping you achieve your quality objectives and navigate the complexities of risk management in the medical device industry.
