As a Master of Science graduate in biomedical engineering and a software developer, Ronny has described, designed and programmed various software projects in the field of medical devices for several years. With his wide-ranging project experience in embedded, desktop, server and mobile application development, as well as in the preparation of the necessary documentation for approval countries, Ronny acts as a link between the worlds of research and development and quality and regulatory affairs.
Leveraging this expertise, Ronny has been advising and supporting manufacturers for more than 10 years in numerous initiatives for improvement and approval in Europe, in the United States and worldwide. He also supports organizations in the implementation and optimization of administration systems, the performance of audits (as a licensed lead auditor for ISO 13485), the preparation of technical documentation for Class I to III products and strategic company decisions.
In order to exchange and share his experience with the industry at large, he serves as an active member of standardization committees at the national and international levels in the areas of software, security and artificial intelligence. He is a speaker and trainer for NSF’s Medical Device Academy as well as many other organizations on a range of regulatory topics, such as cybersecurity, software as a medical device, process and software validation, quality management systems, and risk management.
Areas of Expertise:
- International Standardization
- Medical Device Software
- Advanced Technologies
- Risk Management Systems
- Regulatory Affairs
- Process and Software Validation
- Speaker at Conferences
- Training Instructor