Basha Medical Group based in Riyadh, Kingdom of Saudi Arabia, is specialized in ophthalmic and ENT equipment and supplies. They distribute a broad range of hearing and vision correction products including clinical diagnostic equipment, medical furniture, and surgical supplies, to name a few.
Basha Medical Group contacted ISO Saudi to help them in the implementation of ISO 13485 standards in their company. This was driven by SFDA regulations in the Kingdom of Saudi Arabia.
ISO Saudi is a leading provider of consultancy and certification services for ISO 13485:2016 in the Middle East. We have done various projects for reputed companies in the ISO 13485:2016 standard globally.
The initial step included conducting a gap analysis on the ISO 13485 in Basha Medical Group premises in Riyadh, K.S.A. The team consisted of experts in the ISO 13485 standard and the medical industry. Once the gap analysis was conducted, the top management was briefed of the requirements of the standard and subsequent steps were taken to assist in the implementation of the ISO 13485 standard.
The complete process of preparation of manual, preparation of Medical Device File ( MDF) and the procedures , templates applicable to ISO 13485 and the SFDA regulations, implementation of the medical device standard were done with the help of the team from Basha Medical Group. Warehouse was key part of the project and focus was to ensure implementation of the Medical Device standard requirements in the warehouse , like temperature control, monitoring of temperature and storage of the Medical Devices. The ISO Saudi team also helped the client in internal audit training and internal audit for the ISO 13485.
As on date, Basha Medical Group have completed the stage 2 audit for ISO 13485 and have been successfully recommended for certification.
We, from ISO Saudi, take this opportunity to thank the complete team and top management of Basha Medicals for their continuous support in the whole process of implementation of ISO 13485:2016 standard.