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Smart Tech Solution’s Quality Policy is implemented through a comprehensive Quality Management System

Safety of our patients and consumers,
the quality of data supporting regulatory submissions,
and interactions with our stakeholders.

Smart Tech Solution Quality

Smart Tech Solution leaders are committed to maintaining a quality culture with appropriate systems and processes in place to drive quality-focused behaviors and ensure decision making based on what is best for product quality, patient and consumer safety, and protection of Smart Tech Solution’s reputation and business.
In order to ensure a high quality of its processes and products, Smart Tech Solution continuously builds upon and improves the quality management system in compliance with EN ISO 13485:2016 and MDD 93/47/EEC as well as regulatory requirements. Each person in Smart Tech Solution is accountable for ensuring product quality, patient and consumer safety.

As part of Smart Tech Solution’s commitment to Quality:

Smart Tech Solution’s business is conducted in compliance with applicable quality regulations, codes and standards.

Records, documentation and data are managed in accordance with applicable regulations.

Division leaders are accountable to ensure procedures are in place that adequately define the expectations for work that supports, or directly affects, product quality, product registration and/or data that supports product quality and patient or consumer safety.

Processes for escalating issues to ensure product integrity and patient and consumer safety are in place and consistently used.

All Colleagues have the appropriate education, training, skills and experience to carry out their work competently, in accordance with applicable regulations and Smart Tech Solution policies and procedures.

There is effective oversight of any third party carrying out work on behalf of Smart Tech Solution.

Smart Tech Solution’s Quality Policy is implemented through a comprehensive Quality Management System. Our performance is monitored and regularly reviewed to ensure our standards of conduct meet our high expectations of quality for our patients, customers, and stakeholders.