Sistemir was established in 2011 after founding partner Fabio Valtorta had spent 25 years working in the medical industry. These days we are a well-structured company, with a mix of youth and experience; we manage the CE marking process for all classes of active and non-active medical devices. We dealing mainly with electromedical and implantable devices, software and surgical instruments.
Thanks to constant growth in client numbers and revenue, our company invests in new people every year.
Young people who bring fresh ideas and can develop their industry knowledge, helping us to offer an ever-expanding, rapid and accurate service.
The number of clients we work with has always grown through word of mouth alone. What’s more, the authorities themselves recommend us as a qualified and reliable option. Our work has always been of the highest quality, but we also know the importance of establishing good relationships and mutual trust.
Although our clients’ business underpins our work, we never lose sight of our responsibility towards people’s health. That’s why we have a very practical focus on what really guarantees the effectiveness and safety of every product that we decide to manage.
The medical industry evolves at a constant and frenetic pace. hat’s why we invest so many hours in training each year. It also allows us to share our interpretation with key stakeholders and make absolutely that sure our approach is jointly held.
ur solid financial performance means we can select the clients we want to work with, giving them the reassurance they need around the continuity of our support.
To provide a genuinely effective service we need to believe in the project too.
We are involved in a very high number of audits. The documents that we develop and our approach are subject to continual monitoring, and therefore corrections and improvements. We work with a range of companies and often conflicting evaluation criteria. That means we have a very broad view of the industry and the traits of all those involved.
The number of clients we have worked with for at least 3 years. The regulatory issues that we manage can be subject to legal sanctions and determine a company’s ability to sell a product. We have to build longstanding relationships based on trust and respect.
After more than a year of working together very closely, first with Davide and then with Matteo, I wanted to thank you personally. You are two great professionals [...] it has been an honour to work with people of your calibre, from both a human and professional perspective.
You are two great professionals [...] it has been an honour to work with people of your calibre, from both a human and professional perspective.
Following the standards applied, and with the support of a particularly competent external consultancy \[Sistemir], the company developed a classic quality mangement system with an excellent manual and a series of well-structured and perfectly executed operating procedures.
This year’s inspection visit led to another positive outcome. [...] I’d like to take the opportunity to thank Sistemir for their expert and indispensable support and the timely training to help me carry out my role.
I’d like to thank you on behalf of our staff and, in particular, our guests, who were very happy as well as being struck by your ability to make a ‘boring’ topic an opportunity for training and development for both company employees and the staff directly involved in using the final product.
We had a very positive experience: expertise, lean management of the integration work and excellent "tailoring work" - by that I mean the ability to match the standards required to the needs of our company, which will have the responsibility of applying the various procedures every day.
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