Medical Device Design & Engineering

Our team of experts can help you design and launch your medical device successfully

To be successfully launched on the market, a medical device must not only be functional. It must also fill a need and meet regulatory requirements. We help you develop your innovation from your initial idea or from an existing product to be improved.

We are ISO 13485 certified. It means that our development process for medical devices is fully compliant with the high expectations of the FDA and other healthcare organizations. For you, it’s the assurance that your idea is in good hands.

Our integrated team collaborates on a wide range of devices in the MedTech industry

Digital Health Systems

Patient Monitoring Systems

Cardiovascular Devices

Oncology Devices

Respiratory Devices

Surgical Devices & Catheters


Diagnostics & Dashboards

Connected Medical Devices (IoMT)

Our quality management process follows the highest development standards

ISO 13485:2016

ISO 14971:2019

IEC 62304:2006/AMD1:2015

IEC 60601-1 Ed. 3.2

IEC 62366-1:2015/AMD1:2020
At CLEIO, our integrated design process follows the highest development standards. From concept to market, all our teams are involved and collaborate to make the product evolve according to the recommendations of our quality assurance experts.
Our ISO-13485 certification means that our development activities are controlled and structured by audited and certified processes. These ensure our service quality and the satisfaction of our customers.
In addition, our teams develop your products according to applicable harmonized standards to meet the medical device’s regulatory requirements. It speeds up the time to market and facilitates product approval by relevant authorities.

Discover just a few of the medical innovations we tackled head-on

Want your innovative ideas to create a positive impact?

Our experts got your back.