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Regulatory Essentials in Health Tech: Person Responsible for Regulatory Compliance
Topics of this session
- Responsibilities and roles of the PRRC and the management according to the MDR and IVDR
- Tools for continuous improvement: management reviews, internal audits, mock audits, Post-Market Surveillance, trend analysis, etc.
- Committing key employees and management
- Audits by authorities or notified bodies
- Managing the requirements in multiple markets
- Communication to authorities
Trainers
”I have more than twenty years of experience in the Medical Device industry in various positions, with responsibilities for leading a quality assurance team and overall regulatory compliance according to the ISO 13485 standard, Brazilian (ANVISA), Australian (TGA), US FDA and the EU MDR requirements. I have also worked in the Management Representative role for various companies and most recently as a Person Responsible for Regulatory Compliance (PRRC).
My responsibilities have also spanned the design and development of new Medical Devices, their immaterial property rights (IPR) and supply management. I have worked in start-ups and growth companies for most of my career, holding also the role of a co-founder, which has provided me with a wide perspective into the challenges that young companies face on their way to the international market.”
Target group
Employees assigned with the responsibilities of a PRRC or other responsibilities related to quality management systems, regulatory affairs, and quality assurance. Useful information also for start-up founders.After this session, you
- Understand the obligations of the various economic operators.
- Know the roles and responsibilities of the PRRC and the management.
- Understand the importance of continuous improvement.