Quality and Regulatory Affairs Manager
Are you aware of the impact of IVDR on your business? 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 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. Sign up for the complete training course here or use the button below. If you want to participate in the individual sessions you can choose the ones you are interested in from the links under the session descriptions.
If you order the complete course by 26 September 2022, you will get a -25% discount using the coupon code IVDR2021.
TIME OF TRAINING: 12-13 October 2021,
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 on the market as well as 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 who need to understand at least the basics of the IVDR. Participants will receive a course certificate via email after the course. All attendees are granted free and unlimited access to Entries, the Digital Regulatory Runways for the duration of a full year.
Quality and Regulatory Affairs Manager
Quality and Development Manager
SESSIONS AND DATES:
1. Classification and conformity assessment route, 12 October 2021, at 08.30-10.30 CET
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 the right conformity routes
2. QMS requirements and obligations for economic operators, 12 October 2021, at 11.00-13.00 CET
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 the obligations for various economic operators in the supply chain are.
• How to ensure your QMS complies with the IVDR requirements
• New obligations for economic operators
3. Technical Documentation, 12 October 2021, at 14.00-16.00 CET
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, 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, 13 October 2021, at 08.30-11.00 CET
The 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 the 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, 13 October 2021, at 11.30-13.30 CET
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 on 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, 13 October 2021, at 14.00-16.00
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 you should be tracking in PMS
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.