We support consultants, manufacturers and product developers

Providing world-class consulting and services in the field of medical devices

Services

Medical Devices Engineering

Offering technical and consulting services in all pre-clinical areas of product development.

We tested in collaboration with our clients

We tested in collaboration with our clients

In analyzing the needs of the medical device, we consider the clinical, scientific, regulatory and engineering perspectives and we also design the characterization and safety tests necessary to properly evaluate the device.

We always think about the regulatory process

We always think about the regulatory process

Through our experience in the field of medical devices, we can study and analyze the best way to get our's clients products approved.

Clinical Validation is key for a sustainable innovation process

Clinical Validation is key for a sustainable innovation process

In our worldwide network, we have access to groups of doctors and patients, where we can validate, co-create or idealize the product with real users in a real environment, thus allowing the successful introduction in the market of medical-technological innovations.

Our process

Development Methodology

Product development cycle of medical devices, in areas so diverse as biomaterials, Regulatory requirements and clinical validation.

Idea
01Idea

Literature research, feasibility, design specifications and regulatory assessment

Prototype
02Prototype

In-house protyping process that​ ​ensure the user needs specification is achieved in the​ ​design output specifications

In Vitro Test
03In Vitro Test

The in vitro testing is established​ ​to accurately assess whether the design meets the user​ ​needs requirements.

Animal Testing
04Animal Testing

We has​ ​the knowledge and experience to manage the animal trial process from​ ​the protocol writing to testing of the technology through​ ​our worldpartner facilities.

Clinical Testing
05Clinical Testing

We can manage clinical studies as desired by our​ ​partners with the objective to generating the data required to​ ​achieve global regulatory approval for the technology.

Scale-up Manufacturing
06Scale-up Manufacturing

Through our global manufacturing partner relationship we are able to scale-up and produce medical devices under ISO 13485:2003 and ISO 9001:2008 certified facilities.

Testimonials

What professionals are saying about HydrUStent!

  • A great advantage is that it does not need a second surgery and so the patient has no job loss or admission to hospital, facilitates recovery and professional and social integration. There is a reduction in costs for the health system.

    Dr. Riccardo Autorino, MD
    Richmond, VA, USA
  • The problem of lower urinary tract symptoms (LUTS) and encrustation are the main ones. The short life of this stent means that encrustation will not be a problem, although the LUTS remain.

    Dr. Fin Macneil, MD
    Member at Royal Australian College of Surgeons (RACS) Board of Urology
  • Think stent symptoms can be quite disabling. A more flexible stent would help, like HydrUStent technology.

    Dr. Deepak Batura, MD
    Consultant Urological Surgeon at Ealing Hospital NHS Trust
  • The success of HydrUStent technology will be based on No symptoms (LUTS) and no need to remove while still doing its job of draining the kidney.

    Dr. Hilten Patel, MD
    Professor of Surgery & Urology, and Director of Robotic Urological Surgery, University Hospital North Norway and Director of Surgical Urology Simulation Training, Bart’s & The London, Queen Mary University of London,
  • My reflex response is that a biodegradable stent for kidney transplantation is a gift to the surgeon and the patient.

    Dr. Peter Madras, MD
    Kidney transplant surgeon, Lahey Health