October 02, 2019 - October 02, 2019
/ Europe - HQ Qserve in Arnhem, The Netherlands
Date: 2nd of October 2019
Location: HQ Qserve Group in Arnhem, the Netherlands
Language: English
Costs: Regular € 875.- (including lunch & drinks)
The certificate* is optional, and will cost additional €375.-
Introduction:
The MDR and IVDR require that manufacturers and Authorized representatives have a person responsible for regulatory compliance. Article 15 of the MDR/IVDR determines the expertise and responsibilities. These have been further clarified in the recent guidance MDCG 2019-07. Qserve organizes training for persons that will be appointed by manufacturers or Authorized Representatives as PRRC.
There is an option to receive a personal certificate for this training, showing you have successfully qualified as PRRC. The personal certificate will detail the learning objectives, and if you fulfill the requirements of the MDR/IVDR for qualifying as PRRC (experience and background). The certificate is personal and can be shown to Notified Bodies during audits.
Learning objectives:
• 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 appropriately check the conformity of the devices.
• 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