Quality management: ISO 13485 certification
Our Quality Management System meets the guidelines of the ISO 13485 standard relating to medical devices.
This standard guarantees we can meet our customers’ requirements as well as applicable regulatory requirements.
Here are the key points to know:
- We ensure full traceability on all repairs made to your medical device, with supporting reports.
- We comply with current legislation relating to medical devices.
- We guarantee the safety and performance of your medical device.
- We follow clearly defined procedures.
- We select, evaluate and monitor the performance of our suppliers in order to minimize our risk.
- We are committed to handling your claims as quickly and conveniently as possible.
- We guarantee the reliability of our facilities and the skills of our staff, who are continuously trained.
- We carefully manage our working environment and promote the principles of sustainable development – see our “Environmental Management” charter.
Environmental Management as per ISO 14001/2015
PRS HEALTHCARE is fully committed to sustainable development, namely the constant pursuit of a balance between the environment, society and the economy. This commitment allows us to grow while maintaining the ability of future generations to meet their own needs.
In pursuing this aim, our environmental management is at the heart of our concerns and complies with the ISO 14001: 2015 standard.
Our requirements are aimed at protecting the environment, taking into account our socio-economic needs. Our approach is based on the principles of CSR (Corporate Social Responsibility)
We actively contribute to this protection by:
- Mitigating negative environmental impacts,
- Meeting compliance obligations,
- Strengthening environmental performance,
- Controlling our products’ life cycle phases while minimizing the environmental impact.
At our company, all of our staff and departments are informed of and actively involved in our environmental management process.
Every year, PRS HEALTHCARE devotes a significant portion of its revenue to enhancing its test and repair capabilities.
As manufacturers do not communicate any technical data on their probes, we invest in research, function tests and components to fully understand each new model.
We develop the best processes to restore the original performance of your probes to OEM level and ensure their safety.
Experience and training.
Experience is fundamental when repairing sensitive medical devices like ultrasound probes.
The tens of thousands of probes repaired at PRS HEALTHCARE have taught us the best repair practices and techniques.
Our know-how goes all the way to fault prediction and sound advice on all types of probes.
All of our repairs are carried out in-house by qualified technicians trained according to our quality standards.