Quality

Our Commitment to Patients and Innovation

From the outset, doctors, researchers, and engineers have collaborated closely to provide each patient with a personalised and effective treatment. Over time, this joint effort has helped make advanced medical techniques more accessible to everyone.

At Syneika, our goal is clear: to give as many patients as possible—especially those suffering from chronic neurological or psychiatric pathologies —access to the highest standard of care through neurostimulation.

To achieve this, and with an ongoing focus on safety for both patients and healthcare professionals, Syneika is committed to the following objectives:

  • ✔  Providing care solutions that are increasingly effective, safe, and user-friendly, thanks to non-invasive cortical neurostimulation.

  • ✔  Supporting users in their daily medical practice, helping them grow and improve their care services.

  • ✔  Sharing the best therapeutic practices and most advanced technologies with physicians and their teams, drawn directly from cutting-edge research.

  • ✔  Raising awareness among caregivers and patients about the benefits of neurostimulation and making it easily accessible to them.

Our Quality Commitment

Syneika has implemented a robust Quality Management System designed to achieve these goals. We are committed to meeting our customers’ needs, complying with all applicable regulations, and continuously improving our performance.

This system complies with the ISO 13485:2016 standard and the 93/42/EEC directive on the marketing of medical devices. At the same time, we are actively preparing to meet the requirements of the new Medical Device Regulation (EU Regulation 2017/745) and are already applying the “Transitional Provisions” outlined in Article 120 of this Regulation.

This Quality Management System applies to all Syneika’s activities and to every medical device we design, develop, manufacture, or market.

As a result, the PowerMAG magnetic stimulators and Syneika One neuronavigators are CE-marked medical devices. They fully comply with the stringent safety requirements of the EN 60601-1 standard, as well as all applicable regulations governing medical devices.