Our team can provide guidance and expertise on: intellectual property, concept development, design of experiments, usability (user) studies and human factors engineering, clinical trials, funding opportunities, certification (CE mark) and quality implementation. MD-TEC can help you take your product from bench to market.
Scientific Services
The team has experience in developing biomaterials from concept to finished products for clinical trials (especially those across the drug-device boundary). Key to this process is
Usability Suite
https://vimeo.com/270428932/3969e3b8d4 Human factors engineering is focused on the user (ergonomics) and the use (usability) of medical devices. The utilisation of medical devices in hospital and
Clinical Evaluation
The Medical Device Regulations (MDR) entered into force in May 2017. Manufacturers need to demonstrate that their medical devices meet the stated requirements by carrying
Commercialisation Support
There are multiple aspects involved in the process of CE marking a medical device for commercialisation across the European Economical Area (EEA). An ISO 13485
