Quality and Regulatory Affairs Manager
The new EU IVDR will bring several changes and affects the IVD economic operators in the entire supply chain, like manufacturers, distributors, importers and suppliers. To support operators to comply with the new IVDR requirements, Labquality will offer an online training course consisting of six sessions. The Labquality training course helps your company to understand the key changes and their impact on your business.
The training will provide participants with an overview of the critical changes in relation to new EU IVDR. You can participate in the complete training course or pick the most suitable sessions for you. If you want to participate in individual sessions you can choose the ones you are interested in from the links under the session descriptions.
The participants will understand the impact of the new In vitro diagnostic regulation (IVDR), the most relevant changes compared to the directive, and how the IVDR will impact medical devices already in the market and new medical devices
Our training is intended for quality and regulatory affairs managers and specialists, IVD designers, project managers, marketing managers, operations managers and other responsible persons working in the IVD industry and for other economic operators in the supply chain, and who need to understand at least the basics of the IVDR. Participants will receive a course certificate by e-mail after the course.
TIME OF TRAINING: 12-13 October 2021, online via Microsoft Teams
LECTURE LANGUAGE: English
MATERIAL LANGUAGE: English
PRICE: single session 250 €
Quality and Regulatory Affairs Manager
Quality and Development Manager
SESSIONS AND DATES:
1. Classification and conformity assessment route
The classification of IVD devices is undergoing a significant change under the IVDR. Previously, IVD devices were classified on a list basis, and now under the IVD regulation the classification is based on the risk of the device. In the first session of our IVDR training course we will focus on the key changes and new requirements related to the new IVD device classification system and conformity assessment routes.
• Prerequisites for classification and how to classify your devices
• How to choose right conformity routes
2. QMS requirements and obligations for economic operators
IVDR Article 10 (8) describes the minimum QMS requirements, but it is not the only section of the Regulation you need to take into account when updating your quality management system. In addition to process updates, we will also discuss the role and requirements for the person responsible for the regulatory compliance (PRRC), and what are the obligations for various economic operators in the supply chain.
• How to ensure your QMS complies with the IVDR requirements
• New obligations for economic operators
3. Technical Documentation
Well-structured and adequate content of the technical documentation can significantly speed up the review process by the notified body. In this session we will talk about technical documentation and general safety and performance requirements (GSPR). What is a good way to demonstrate that you have all the evidence to show that your IVD device complies with the GSPR?
• Interpreting the requirements for technical documentation
• How to create files that are easy to use
4. Risk Management
Risk management system needs to be maintained through the whole device lifecycle and aligned with other quality processes such as performance evaluation, usability, feedback, change management and CAPA process. In this session we will also review the links between IVDR, ISO 14971:2019 and ISO 13485:2016.
• Interpreting the requirements for risk management
• Special risk management considerations for IVDs
• Risk management system alignment with other quality processes
5. Clinical performance evaluation
The IVDR mandates to compile a performance evaluation report (PER) for each device, addressing scientific validity, analytical performance, and clinical performance. The report shall be part of the technical documentation. The focus in this session will be in the requirements and key factors for compliance.
• Performance evaluations – what data do you need and what sources you can use
• Requirements and expectations for Scientific Validity, Analytical Performance, Clinical Performance
6. Post market surveillance
In this session we will focus on the PMS and vigilance requirements and their relations to ISO 13485:2016 and ISO 14971:2019 (and certain IMDRF guidelines). We will also get familiar with the terminology and incident and adverse event reporting essentials.
• Interpreting the requirements for post-market surveillance
• What should you be tracking in PMS
The trainer was very professional and the training material was well prepared, thank you very much!
I got some good ideas for developing my own process.
The training as a whole was very successful and I received a good package of information.
BILLING AND CANCELLATION POLICY
Participation in the training can be cancelled two weeks (14 days) before the event free of charge. For cancellations made after this, we will charge 50% of the participation fee, except for cancellations made one week before the event, we will charge a 100% participation fee.
Cancellations are always made in writing to: firstname.lastname@example.org.
The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to: email@example.com. The participation fee will be invoiced immediately after the event. The training session will be confirmed to the participant by e-mail about a week before the event. Labquality reserves the right to cancel the training session due to a small number of participants.