Berkin Güler, B. Sc.

Manager Medical Device Consulting & Lead Auditor at NSF Medical Device & IVD Consulting

Speaker

As a Manager for Medical Device Consulting Berkin Güler is responsible for a group of consultants in the field of Quality Management and Regulatory Affairs at NSF PROSYSTEM GmbH, which is one of the world's leading consulting and service companies in medical technology based in Hamburg, Germany. After attending medical school and successfully completing his Bachelor of Science degree in Biomedical Engineering, Mr. Güler worked in the area of Regulatory Affairs.

At NSF PROSYSTEM he established services on Post-market Surveillance (PMS) and Vigilance particularly on the European Regulations on Medical Devices. Since then, his professional focus has been on Post-market Surveillance and Post-market Clinical Follow-up. Besides creating and reviewing documentations on that matter, Mr. Güler has furthermore actively supported the creation and implementation of various procedures in the industry, particularly those on PMS and its interface procedures such as Complaint Handling, Reporting to Regulatory Authorities, Risk Management, CAPA or Clinical Evaluation.

In addition, Mr. Güler is a Lead Auditor of Quality Management Systems according to ISO 13485. He also conducts trainings on the general European & U.S. medical device submission requirements as well as PMS, Risk Management, Clinical Evaluation and Quality Management Systems for manufacturers.