Medical Device Engineering

We created MEDICAL DEVICE ENGINEERING S.A.S to bring innovators the missing link in the development of their medical devices and disposables.  The concept of your therapy, or surgery has been proven from the medical point of view (PoC) and you need a device?  Or you may simply have an idea and do not know where to start to make it concrete? Our Philosophy: A team composed of both Scientists & Engineers (plastics processing) to better understand each other, and to make the link between your medical matters, and the best technical approach to design & industrialize it. Our Services: We offer Taylor made services according your needs &/or state of progress of your project: - From functional & risk analysis to CAD Design - Through prototypes, and until the proof of concept - We also develop your injection moulds & related toolings (e.g. silicone / assembling) - We carry your IQ / OQ / PQ type process qualifications - We may manage your validations & regulatory files (CE / FDA) - Finally, we offer manufacturing in cleanroom services We are able to build your Technical file from A to Z, in order to drive you until your device certification (CE marking, FDA 510 (k) …etc), as we know how to handle your design to meet the essential requirements. Some of the fields we operate in : - Biotechnologies & Pharma. - Ophthalmology - Surgery(ies) - Orthopaedics - Urology - Diagnosis - …Etc. Please find herewith few examples of recent developments carried out by MDE for stakeholders. Those may allow you to better understand our field of action: - IOL regular & pre-loaded injectors (intra-ocular lens) - Microscope disposable for cell growth real-time monitoring - Plastic consumable for adult stem cells “in vitro amplification device” - Mandibular anti-snoring device - Bio-resorbable implants & Stapler - Diagnosis kit (faecal sampling) - Bioreactors (stem cells, adherent & suspension…) - Blood centrifugation bowls / collection vessels - etc.