Quality policy

1.1- Pragmatic Diagnostics aims at becoming a major technology transfer player and R&D-partner for the international IVD industry.

1.2- It is the policy of Pragmatic Diagnostics to provide customers with design and development services that meet or exceed the agreed requirements, adding value to their R&D investment.

1.3- We are fully committed to always comply with ISO 13485:2016 quality requirements and, when agreed with the customer, the following regulations: Regulation (EU) 2017/746 / EU In Vitro Diagnostic Medical Device Directive 98/79/EC and the USA 21 CFR Subchapter H – Medical Devices for our products under development and services. With that in mind, we will prepare the appropriate documentation to ensure transfer from development to production and to facilitate regulatory submissions compliant with the aforementioned regulations.

1.4- In Pragmatic Diagnostics, we are also committed to maintain the effectiveness of our Quality Management System. In addition, we strongly believe that the continuous improvement of our Quality Management System is the tool to achieve our purposes. For that reason, we use risk-based approaches in our Quality Management System, and our procedures are constantly reviewed and updated.

1.5- We do believe that Quality affects the entire organisation at all levels. Not only is the staff trained in the job position duties, but also in our Quality System and encouraged to participate in its improvement.