EU 2017/745 MDR Technical File Preparation

  • Device description and specifications
  • Information to Be Provided by the Manufacturer
  • Design and Manufacturer Information
  • General Safety and Performance Requirements
  • Product Verification and Validation
  • Technical Documentation on Post-Market Surveillance


Lecturers

Başak Baranoğlu has started her career in 1999, after successfully completing a BS degree in Biology from METU and MBA from Bilkent University in 1999, and now is an accomplished veteran in the field of  Quality Management Systems for Medical Devices.

After holding various senior management positions at Bıçakcılar and Alvimedica, she established AdviQual with a goal to provide consultancy and technical training in the field of quality management in particular to Medical Devices.

She leads the company with her team of accomplished quality management consultants to provide end-to-end solutions to medical device manufacturers and works in collaboration with foreign experts and AdviQual's international partners.