Presented by R&Q Director of Minnesota Operations / Principal Consultant - and ISO Technical Committee 210 (TC210) and Working Group 1 (WG1) member - Mark Swanson, this session outlines how organizations should establish a risk-based approach as outlined in the requirements of ISO 13485:2016, and the changes associated with implementation of the new edition of ISO 13485. In this session, we will establish a basic understanding of the application of the risk-based approach in your QMS process, the evidence that will show this implementation to auditors, and how these are implemented in your update to your QMS.
MDSAP can potentially offer a variety of important advantages. While currently optional for FDA, it will be mandatory for Health Canada in January of 2019. Times will be busy with limited qualified registrars, ISO 13485:2016 implementation by March 2019, and EU MDR by 2020. You will leave this session understanding MDSAP inside and out and be sufficiently prepared. Having been on the receiving end of two MDSAP audits, Connie Hoy of Cynosure Inc. (recently acquired by Hologic) will describe her successful first-hand experiences and offer step-by-step practical advice on how to adequately prepare for MDSAP and be successful. Her recent real-world case studies provide the perfect examples of what to do and how to accomplish it.
The Case for Quality has transformed into to a movement for quality beyond compliance. This important initiative between the FDA and medical device industry has moved past the metrics and competencies of quality professionals into maturity models and data analytics that will drive the value proposition of medical devices. Come and hear an update from industry professionals and what you can do in preparation for the next steps coming in this important industry collaboration.
The upcoming EU MDR changes are significant, potentially impacting your device classification and the need for clinical data. Considering the overall timeline – including ISO 13485:2016 (March 2019) and MDSAP (if selling in Canada; Jan. 2019) – it will be difficult to get on notified bodies’ schedules. The time to plan and act on these changes is now. Your technical files, design dossiers, quality system documents, clinical plans, labeling (including UDI), software, and more will be affected. Plus new requirements are coming into play, including Eudamed and periodic safety update reports (PSURs). This session will describe what to do now, what to keep your eye on, and real-world examples that show how industry is working through the changes. Interpretations will evolve, but this session will absolutely help you navigate the process.
Clinical evaluation requirements have been changing, with the latest impact coming from MEDDEV 2.7.1 Rev 4. Preparing for and meeting these requirements is important because the grace period offered by some notified bodies is ending and clinical evaluation reports (CERs) are being audited for compliance with the latest MEDDEV revision. Furthermore, the European Medical Devices Regulation (MDR) will impact CERs as well once the regulation comes into force. It is important to be proactive to ensure CERs will meet your notified body expectations. We will discuss the key changes and additional CER content required so that you can ensure your CERs are in compliance with MEDDEV Rev 4. Looking ahead to MDR enforcement, we will also discuss how the new regulations impact your CERs. Finally, we'll look at the common mistakes manufacturers make and how to avoid them, suggestions from a Notified Body perspective, and case studies of the most common problems related to Rev 4.
The regulations at the federal level mandate that healthcare organizations, financial institutions, and federal agencies should protect their systems and information. Presented by R&Q Senior Principal Consultant Marilyn Waxberg, this session will outline the regulations and FDA guidance that shape cybersecurity, and outline the management of cybersecurity throughout the lifecycle of the product.