"Speaker was excellent, one of the best I have heard. Knowledgeable and clear."
"LOTS covered at a brisk clip. Excellent! But we are really going to need those slides to digest it all. :-) Thanks!"
"It has been really helpful to see what is the situation in other companies also. Thank you!"
"Great webinar! Information was clear and it was a good update on the time frame for MDD/MDR compliance."
"That was a great webinar, thank you!"
"Great webinar, so informative!!"
The EU MDR date of application is approaching faster than you might think.
With changing schedules and increased scrutiny from the notified bodies, as well as an overwhelming amount of information out there, it can be difficult to understand the impact of the new regulations and determine where and when to start. 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).
Compound all of this with varying dates for compliance, and the task can seem impossible.
The goal of this webinar is help you better understand the major changes coming, the planned timing, how to realistically plan for the impact, and what you can do today to start getting ready.
We will also cover what to keep an eye on and provide some real-world examples that show what manufacturers and notified bodies are doing because of the changes.
About the presenter
Project Engineer, Regulatory & Quality Solutions (R&Q)
Brian Hockett is a Project Engineer at Regulatory & Quality Solutions (R&Q). Brian is a skilled medical device professional with experience in design, development, risk management, regulatory submissions, and quality management systems. He has worked in both startups and large medical device organizations, and has been a key member of corporate integration and remediation teams. Brian has helped lead quality system updates and implementation for ISO certification, FDA and notified body audit preparation and defense, as well as directed design and development efforts, and design quality assurance projects.
Brian currently works with companies to develop strategies and plans to meet the new EU MDR requirements for their technical documentation, post-market surveillance, and QMS. Brian has a Bachelor of Science Degree in Biomedical Engineering from Case Western Reserve University.