Performed a European based User Experience study for GEDSA to establish a standard enteral feeding connector to reduce the occurance of mis-connections in a healthcare or home environment. The study was conducted in Spain, France, Italy, United Kingdom, Sweden and the Netherlands. Due to our usability expertise and can-do attitude, we were able to design the study, recruit 48 clinical users, conduct the study and complete the final report in five weeks.
Provided various Regulatory Strategies to companies involved in medical device, IVD, Biologics and Pharmaceutical industries. Provided 510k and CE Mark support companies launching products in the U.S. and EU.
Salvaged and rewrote QMS for upcoming FDA audit. Audit was a success with zero write-ups.