Date: December 5th, 2019
Time: 9 am - 5 pm PST
Cost: $ 990.-
The certificate* is optional, and will cost an additional $425.-
In-Depth Training | Q & A | Open Discussion
December 5th or January 17th | Limited Seating Available | Register Today
The MDR and IVDR require that manufacturers and Authorized Representatives have a Person Responsible for Regulatory Compliance (PRRC). Article 15 of the MDR/IVDR determines the expertise and responsibilities of the PRRC. These have been further clarified in the recent guidance MDCG 2019-07.
Qserve is providing in-depth training for persons that will be appointed by manufacturers or Authorized Representatives as the PRRC.
Option to receive a training certificate, proving you have successfully qualified as a PRRC. The certificate will detail the learning objectives and certify that the requirements of the MDR/IVDR have been met in both experience and background. The certification can be viewed by Notified Bodies during audits.
• Understand the background of MDR/IVDR to understand PRRC requirements and where they are coming from.
• What are the roles and responsibilities of PRRC?
• Qualifications of PRRC.
• Relation of PRRC and your QMS.
• Learn how to check the conformity of the devices appropriately.
• Understand what checks are proportionate to the risk class and the type of device.
• How to keep the technical documentation and the EU declaration of conformity up-to-date.
• Checks to fulfill for post-market surveillance obligations.
• Reporting obligations for recording and reporting of incidents and field safety corrective actions.
• What to do as PRRC if there are devices undergoing clinical investigation (MDR) or performance studies (IVDR)?
• Liability of the PRRC.
Who should attend:
• Persons that will be responsible for regulatory compliance
• Authorized representatives
• RA manager, RA director, QA manager, QA director
• Professionals preparing for the MDR/IVDR