Looking back
Towards the future

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.

Main objective

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.

Our numbers


Total clients

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.


Medical devices certified

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.


Training hours every year

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.

+ 0 %

Average annual revenue growth

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.


Audits per year

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.

What people say

Contact us

Requirement analysis

Use the details in the contact section to get in touch: we can give you more information, organise an initial meeting, create a bespoke service, or put together a dedicated quote.