Nick Burmester

Nick Burmester established and leads NSF’s TechFile Factory, which focuses on the evaluation and preparation of technical documentation for international medical device registrations, and has over 12 years’ experience in the medical device industry. Nick studied medical engineering at HAW University of Applied Science in Hamburg, Germany.

Nick’s expertise covers international medical device registrations, from Class I to high-risk devices. He is also responsible for implementing various quality management systems and risk management systems and for preparing technical documentation for many manufacturers.

He is a certified ISO 13485 lead auditor and has performed countless supplier and due diligence audits for clients worldwide. He is responsible for the quality management systems ISO 13485 and ISO 9001 at NSF’s Hamburg office.

Additionally, he is a well-known speaker at conferences and provides training on various topics related to international regulatory affairs for TÜV SÜD and other platforms.

As part of his current function as Senior Manager, Medical Device Consulting, Nick has established the TechFile Factory division. The TechFile Factory focuses on the evaluation and preparation of technical documentation for international medical device registrations, including the Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

Areas of Expertise:

• International Regulatory Affairs (e.g. Europe, U.S., South Korea, Canada, Australia)
• Technical Documentation
• EU Medical Device Regulation (MDR)
• Risk Management Systems
• Usability and Human Factors
• Medical Electrical Equipment
• U.S. Regulations and FDA Requirements
• Quality Management Systems
• Audits and Inspections
• Training Instructor