Berkin Güler is the head of the medical devices consulting team and has more than 10 years of experience in the medical device industry, of which he has spent seven at NSF. He is a subject matter expert for post-market surveillance (PMS) services at NSF, which is one of the world’s leading consulting and service companies in medical technology. After attending medical school and successfully completing his Bachelor of Science degree in biomedical engineering, Berkin has worked in the area of regulatory affairs and quality management.
At NSF, he has established services for post-market surveillance and vigilance, with a particular focus on the European regulations for medical devices. Since then, his professional focus has been on post-market surveillance and post-market clinical follow-up. In addition to creating and reviewing documentation in those subject areas, Berkin has actively supported the creation and implementation of various procedures in the industry, particularly those for PMS and its interface procedures, such as complaint handling, reporting to regulatory authorities, risk management, CAPA and clinical evaluation. Berkin is also a lead auditor for quality management systems according to ISO 13485 and the MDSAP. He conducts trainings on PMS, risk management, clinical evaluation and quality management systems for manufacturers.
Areas of Expertise:
- Post-Market Surveillance
- Post-Market Clinical Follow-Up
- Risk Management Systems
- Quality Management Systems
- Clinical Evaluation
- Audits and Inspections
- Regulatory Affairs
- EU Medical Device Regulation (MDR)
- Medical Device Single Audit Program (MDSAP)