Categories: MedDev Speakers 2023

Miriam Boles is the head of central administration of medical devices in the Egyptian drug authority. She holds a bachelor degree of pharmaceutical sciences from an established Egyptian university and a master degree in business administration from Arab Academy for Science, Technology & Maritime Transport, (AASTMT), where she specialized in supply chain.

Miriam worked for two decades in various positions in medical device regulatory governmental sector. Prior to her current role, Miriam began her career as medical devices registration reviewer, then senior reviewer, afterwards , director of medical devices unit.

From November 2020, Miriam became the head of central administration of medical devices.

Her goals in this role are to develop and implement strategic plans for premarket regulations of medical devices and IVDs in pursuit of EDA’s mission and vision of providing safe, and effective medical devices.

The most significant achievements that took place under her leadership :

  • Enhancing the localization of many medical devices and equipment.
  • Establishing an online platform (MeDevice) for automating administrative
  • workand electronic archiving.
  • Issuing guidelines to regulate all procedures related to premarket approvals, unique device identification and labelling requirements.
  • Developing a procedure to regulate the import and circulation of laboratory and diagnostic reagents for the first time in the Arab Republic of Egypt.
  • Unique device identification(UDI) was applied to all medical devices that are circulated in the local market .

Miriam Boles is an experienced hard worker driven by passion. She takes pride in providing the best possible achievements. She believes in team work, power of positivity, motivation by task, and interested in data analysis, problem solving beside her sustainable passion to be kept updated with medical devices and IVDs regulations all over the world.