Regulatory
Services
Digital-first
Full Service
Consultancy
Preclinical
Services
Internationality
Quality
Services
Future-ready
Mindset
Clinical
Services

We are proud to be a multidisciplinary team with experience in design and development, engineering and certification of medical devices, combination products and in vitro diagnostics. We work with passion, boldness and dedication, with the aim of empowering businesses who share our philosophy of growth and constant improvement in order to bring to market sustainable solutions that improve patients’ quality of life.

Through an international network and a solid relationship with European notified bodies, competent authorities, research institutes and laboratories, we offer scalable and customizable regulatory, clinical and digital services that guarantee the sustainability of every single project.

Transparency for us means being able to offer different solutions while constantly highlighting risks and benefits, costs and timings with extreme openness and reliability.

For this reason, we take care in choosing which challenges we commit to. Because mutual trust lies at the heart of the successful completion of any project. As soon as we take on your project, we don’t only explore your needs, but we also carefully analyze the essence of your vision of the future in order to fully understand it.

Competitive
edge

Competitive
edge

We are proud to be a multidisciplinary team with experience in design and development, engineering and certification of medical devices, combination products and in vitro diagnostics. We work with passion, boldness and dedication, with the aim of empowering businesses who share our philosophy of growth and constant improvement in order to bring to market sustainable solutions that improve patients’ quality of life.

Through an international network and a solid relationship with European notified bodies, competent authorities, research institutes and laboratories, we offer scalable and customizable regulatory, clinical and digital services that guarantee the sustainability of every single project.

Transparency for us means being able to offer different solutions while constantly highlighting risks and benefits, costs and timings with extreme openness and reliability.

For this reason, we take care in choosing which challenges we commit to. Because mutual trust lies at the heart of the successful completion of any project. As soon as we take on your project, we don’t only explore your needs, but we also carefully analyze the essence of your vision of the future in order to fully understand it.

We understand your challenges because we treat them as our own, in order to imagine and jointly realize innovative solutions capable of accelerating the regulatory and commercial processes of your medical devices, combination products and in vitro diagnostics for the benefit of patients.
Proud to be an ISO 13485 certified company, we are perfectionists, proactive and ambitious. We constantly develop added value services to offer you the experience and the reliability of a consolidated international company, still maintaining the responsiveness and creativity of a start-up.
We support you in your desire for growth and continuous improvement, offering regulatory support, digital solutions and full-service CRO assistance with a unique specialization in medical devices.
Ours is a next generation approach: lean and agile, eager to explore, evolve and grow in its complexity together with you.

We understand your challenges because we treat them as our own, in order to imagine and jointly realize innovative solutions capable of accelerating the regulatory and commercial processes of your medical devices, combination products and in vitro diagnostics for the benefit of patients.
Proud to be an ISO 13485 certified company, we are perfectionists, proactive and ambitious. We constantly develop added value services to offer you the experience and the reliability of a consolidated international company, still maintaining the responsiveness and creativity of a start-up.
We support you in your desire for growth and continuous improvement, offering regulatory support, digital solutions and full-service CRO assistance with a unique specialization in medical devices.
Ours is a next generation approach: lean and agile, eager to explore, evolve and grow in its complexity together with you.