We are delighted to partner with Medodan to bring their 50+ years of combined expertise of developing medical devices across over 25 projects to our partners.
Previous projects include
- Bruxism management device – using surface electromyography (EMG) and cutaneous electrical stimulation
- Drop foot stimulation device, active implantable medical device using peripheral nerve stimulation
- Tongue control device, intra-oral appliance for control of computer/wheelchair
- Hearing test devices including Auditory Brainstem Responses (ABR)
- Vagus nerve implant, recording of vagus nerve activity and stimulation of vagus nerve for reduction of blood pressure
- Brain Monitoring (Electroencephalography, EEG)
- A majority of the devices were taken all the way from initial idea to CE-mark and FDA 510K clearance
- Together they are the inventors on more than 25 patent families
Key competences include:
- Project management, including management of contract developers
- Development of analog and digital hardware for implantable, portable and stationary medical devices
- Software development, including embedded microcontroller software, Android and iOS mobile applications and PC-based software
- Development of full product design dossier including risk analysis, suitable for CE-marking and FDA clearance
- Development of quality management systems and integration of quality management in design and production
- Management and development of intellectual property portfolio
- Outsourcing of production (Malaysia and China)
- Design of clinical trials and writing of protocols according to Good Clinical Practice.
- Analysis of results from clinical trials and writing of scientific articles for publication in peer reviewed journals.
Management of regulatory affairs, such as communication with notified body and management of regulatory submissions