1. Introduction

Valor Implant is a company that seeks to provide solutions for surgeons and patients through personalised, custom-made treatments, offering solutions that include surgical planning and implant design in the fields of orthopaedic and trauma surgery, maxillofacial surgery, oncological surgery, neurosurgery and paediatric surgery, carrying out surgical planning, custom-made implants and surgical guides, among others, in order to ensure the satisfaction of each of the interested parties, and above all that of the patient, deploying a company culture that regards everything we do as open to improvement, creating a working environment where self-improvement, participation and engagement become an intrinsic motivation reflected in our actions and results, all of this while guaranteeing compliance with current legislation in all areas affecting the organisation’s activity.

This Policy constitutes the reference framework for establishing, monitoring and reviewing the quality objectives of Valor Implant, aimed at guaranteeing the safety and performance of custom-made medical devices throughout their entire life cycle, as well as compliance with applicable legal and regulatory requirements, including Regulation (EU) 2017/745 on medical devices for custom-made products, together with the rest of the applicable regulations on quality, environment and data protection.

The optimisation of the medical process has a significant impact on hospital care, reducing production times and increasing availability with shorter delivery times, shortening the wait before surgery and minimising the risk of hospital infections.

Custom-made implants adapt naturally to the patient, enabling faster recovery and a considerable reduction in the likelihood of undergoing further surgeries, improving quality of life in the long term.

The combination of more efficient processes, personalised care and rapid approaches to medical care results in a positive experience for patients and better outcomes in terms of health and wellbeing.

To this end, an effective quality management system for custom-made medical devices is established, based on a risk-based approach oriented towards patient safety, which fosters the continuous improvement of the effectiveness of the system on a permanent basis.

2. Mission

The mission of Valor Implant is to offer added-value solutions that improve society, patients, surgeons and our clients, achieving results based on smart objectives — objectives that must be specific, measurable, achievable, realistic and time-bound — with the ultimate aim of ensuring that clients perceive real value in the surgical planning and implant design products and services provided by Valor Implant, and standardising personalisation to make it accessible to all patients.

3. Vision

The needs of clients and patients in the healthcare field — specifically in orthopaedic and trauma surgery, maxillofacial surgery, oncological surgery, neurosurgery and paediatric surgery — are becoming increasingly complex and require specific expertise to offer solutions that meet their needs. Valor Implant must be a strategic life-cycle partner for all its clients, going beyond their expectations by creating solutions that add value and are sustainable, at a highly competitive cost, setting a benchmark in quality, technical and technological excellence, digitalisation and process innovation for patients and the industry as a whole.

4. Values

A series of values must define Valor Implant in all of its internal and external relationships. These values are:

It is important to focus on the needs of clients, surgeons and patients, listening, observing, learning and maintaining a global view of the business and of Valor Implant’s sectors of activity.

Clients expect us to act with agility, to be capable of adapting to change in pursuit of efficiency, to take responsibility for our actions or lack thereof, and to create value by learning from mistakes.

5. Conclusion

To implement this Quality Management System Policy, Valor Implant has established a management system based on the international standards UNE EN ISO 9001:2015 for Quality and UNE EN ISO 13485:2018 for Medical Device Quality.

The Organisation is aware of and understands this policy and the way in which each individual contributes to its fulfilment.

The management of Valor Implant is responsible for ensuring that this policy is communicated to and understood by the entire organisation and complied with, that it is available to interested parties who request it, and for its periodic review to ensure it remains adapted to regulations and the requirements of all parties involved, providing the necessary resources for this purpose.

This policy is reviewed, controlled and updated during management system reviews, in order to guarantee its continued suitability, adequacy and effectiveness with respect to the reality of the organisation and the needs of our clients and patients.

6. History of Revisions