Services
Medical devices engineering
Offering tecnhical and consulting services in all pre clinical stages of product development
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.
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.
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.
Our process
Development Methodology
Product development cycle of medical devices, in areas as diverse as biomaterials, regulatory requirements and clinical validation.
01Idea
02Prototype
03In Vitro Testing
04Animal Testing
05Scale-up Manufacturing
06Clinical Testing
Specialized services & technologies
We provide specialized testing in urology and gastroenterology, with a wide range of mechanical, physical/chemical and biological characterization techniques available.
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
Standardized Testing
Certified Prototype Development
Our medical device engineering team offers a range of services to address your product development needs.
Supercritical Carbon Dioxide
Innovative Sterilization, Deep cleaning and impregnation Process
Supercritical carbon dioxide process in ISO 6 cleanroom, for medical devices development and sterilization process.
Medical Coating Formulation
Pharma compliance technology in-house allows us to develop and test, together with our client's innovative coatings formulations with a different purpose, such us:
- Antimicrobial
- Wettability
- Biocompatibility
- Reduced friction
Clean Room (ISO 6)
Our in-house clean room allow us to prepare prototypes and clinical samples in the required conditions
Radiopacity Testing ASTM F640-12
In biomedical and life science fields it is very important to quantify and validate the radiopacity of a device. Radiopacity allows the correct placement of a given device by facilitating its localization.
Hydrumedical can provide testing according to the international standards in-house or in our client facilities.
Testimonials
What professionals are saying about Hydrumedical!
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