Mr. Zuta is an experienced medical device regulatory and quality assurance professional with over 24 years of medical device industry experience collaborating with small, medium, and big sized companies on early and late stages in the product life cycle. Specializing in a broad range of services, his role within the DRA group focuses on the following areas:
- Global regulatory strategy and Compliance Planning
- ISO 13485 QMS auditing
- Development of Global Medical Device applications (e.g., USA, Canada, EU, Malaysia, Thailand, Korea, Japan, Australia, Singapore, Saudi Arabia, Brazil, etc.)
- ISO 13485 QMS implementation
- Gap analysis and development of medical device applications or QMS processes
- US and EU agency/notified body interactions
- Post-production agency interactions (e.g., post market surveillance, medical device reporting and field safety actions)
- Regulatory advice and training
- EU MDR support
- Clinical evaluation reviews
Prior to joining Dunn Regulatory Associates, Mr. Zuta was the CEO of MEDDEV Consulting AB. He holds a Master’s degree in Chemistry from Gothenburg University (Sweden), QMS/Lead Auditor Certification (ISO 13485:2016) and is Regulatory Affairs Certified (EU RAC).