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.
Through our experience in the field of medical devices, we can study and analyze the best way to get our clients´ products approved.
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.
Product development cycle of medical devices, in areas as diverse as biomaterials, regulatory requirements and clinical validation.
03In Vitro Testing
We provide specialized testing in urology and gastroenterology, with a wide range of mechanical, physical/chemical and biological characterization techniques available.
(Surface detailed characterisation, precipitates formation analysis)
(Continuous monitoring of leachables)
(Bacterial screening, CFU count, biofilm formation)
Our medical device engineering team offers a range of services to address your product development needs.
Innovative Sterilization, Deep cleaning and impregnation Process
Supercritical carbon dioxide process in ISO 6 cleanroom, for medical devices development and sterilization process.
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:
- Reduced friction
Our in-house clean room allow us to prepare prototypes and clinical samples in the required conditions
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.