Services

Medical devices engineering

Offering tecnhical and consulting services in all pre clinical stages of product development

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We give you all perspectives in product development

Our team will help you developing your product from proof of concept to preclinical pilot batches. We evaluate the clinical need for your product and consider clinical, scientific, regulatory and engineering viewpoints. We also perform safety tests and validation in small and large animals.

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We 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 clients´ products approved.

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We access clinical needs with key opinion leaders

We built a worldwide network that allow us to idealize, co-develop and validate your product in close relation with key players (clinicians, patients and others), thus ensuring a successful introduction of medical- technological innovations in the market.

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Our process

Development Methodology

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

01Idea

Literature research, feasibility, design specifications and regulatory assessment

02Prototype

In-house prototyping process that ensures our clients' requirements are met in terms of design specifications

03In Vitro Testing

In vitro testing is established​ ​to accurately assess whether the design meets clients´ requirements

04Animal Testing

We have ​the knowledge and experience to manage small and large animal trial processes from​ protocol writing to technology testing in collaboration with our world-partner facilities

05Scale-up Manufacturing

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

06Clinical Testing

We can manage clinical studies as desired by our​ clients with the objective to generate the data required to​ ​achieve global regulatory approval for the technology.
Specialized services & technologies

We provide specialized testing in urology and gastroenterology, with a wide range of mechanical, physical/chemical and biological characterization techniques available.

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  • Medical devices testing under simulated dynamic physiological conditions

    • Encrustation studies

      (Surface detailed characterisation, precipitates formation analysis)

    • Degradation assays

      (Continuous monitoring of leachables)

    • Bioburden evaluation

      (Bacterial screening, CFU count, biofilm formation)

  • Devices functionalization

    • Compound impregnation
      • Homogeneous distribution of the compounds throughout the device
      • Long-lasting and prolonged effect
      • A wide variety of compounds can be impregnated
  • Clean room (ISO 7)

    • Medical device prototype design and development under ISO 13485
Facilities

Certified Prototype Development

Our collaboration with different partners allow us to provide the adequate support to our clients in all stages of medical devices development

Clean Room (ISO 7)
Our in-house clean room allow us to prepare prototypes and clinical samples in the required conditions
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Testimonials

What professionals are saying about HydrUStent!

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Address

Avepark - Parque de Ciência e Tecnologia
Zona Industrial da Gandra

4805-017 Barco - Guimarães - Portugal

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