The Public Relations Department of the British Embassy in Sarajevo issues a press release which we bring in its entrity
Press release, June 23rd 2021
BIH made ventilator prototype will go into the clinical study and evaluation phase conducted in BiH for the first time
The Medical Devices Testing and Evaluation Centre (MD-TEC), TMD group Gradacac and Tuzla University Clinical Centre in the presence of Her Majesty’s Ambassador Matt Field have signed an agreement today for the clinical study and evaluation of TMD Group ventilator prototypes. The clinical study and evaluation will be conducted at Tuzla University Clinical Centre.
Last year at the height of COVID-19 pandemic, TMD group Gradacac designed and produced a ventilator prototype, which later underwent extensive testing at theMedical Devices Testing and Evaluation Centre (MD-TEC) in the UK. We have now reached the most critical phase of the process- clinical study and evaluation of this medical device which has not been previously performed in Bosnia and Herzegovina. The agreementsigned today will enable Tuzla University Clinical Centre to implement the necessary and relevant medical standards in clinical study of medicine equipment and devices with the help and guidance from the Medical Devices Testing and Evaluation Centre (MD-TEC) and proceed with ventilator prototype clinical trials. This is a major step in ventilator prototype certification process in line with the highest international standards. Completing this step would mean all pre-conditions are met for large scale ventilator production.
By completing this process, TMD Group has initiated the development of a new industry branch in Bosnia and Herzegovina- medical components and device manufacturing and enabled the healthcare sector to develop relevant knowlegde and competences as well as create synergy between the UK and BiH healthcare sectors.
TMD Group Director, Damir Hanić has stated: „ After receiving MD-TEC analysis results, we have strenuously worked on design improvements, we have prepared the declaration of EC certificate conformity, established a new company -TMD Medical Components and Devices which will work exclusively on medical devices developement and production and establied a cooperation with Tuzla University Clinical Centre on clinical studies and evaluation of our product. I would like to express our gratitute to MD-TEC and the UK experts on their wholehearted support, to British Embassy Sarajevo as well as ambassador Field for enabling us to extend our project’s scope which now encompasses MD-TEC’s support to healthcare sector in Bosnia and Herzegovina.“
Tuzla University Clinical Centre Director, Alen Kamerić MD, highlighted that he was quite pleased that Tuzla University Clinical Center is conducting a clinical study for TMD ventilator prototype and added: „We are quite happy that our staff will have the chance to enhance their knowlegde and increase competence and in line with the highest medical standards and through expert help and support from MD-TEC from University HospitalsBirmingham NHS Trust in the UK. Tuzla University Clinical Center is working constantly on developing their operations and we hope that our contribution to Bosnian made ventilator development will additionally strenghten our healthcare system.“
The Medical Devices Testing and Evaluation Centre (MD-TEC) based at University Hospitals Birmingham NHS Foundation Trust in the UK, is pleased to provide on-going support and advice to TMD group and Tuzla University Clinical Centre as they begin the clinical study and evaluation of the TMD ventilator. MD-TEC carried out extensive testing of the ventilator prototype in December 2020 and was impressed by the level of functionality and usability achieved by TMD. Professor Clutton-Brock, MD-TEC Clinical Director said “ We are looking forward to seeing the potential of this medical device realised. Supporting a collaboration, even remotely, will demonstrate how effective and productive knowledge sharing, during such difficult times like the pandemic, can be.”
„I am very pleased that shortly after MD-TEC conducted their analysis, TMD’s ventilator prototype has reached clinical study research phase in Tuzla University Clinical Centre. This is the first time MD-TEC has provided support for a medical device clinical study conducted in Bosnia and Herzegovina and I am certain that this will open more certification, production and procurement opportunities.” Her Majesty’s Ambassador to Bosnia and Herzegovina, Matt Field stated.