"It was excellent. Lots of good information. Our process has been reviewed a few times by our NB with no issues, but there are things you guys presented that will make our process even more robust. So, thank you. Well done."
"Fantastic presentation. I've been struggling with SOTA for some time, and it really helps to learn how other writers are approaching the issue."
"Good Job guys!!! I really like the way the webinar is structured."
"Very good presentation. Thank you!"
"Very good - like/agree with the point that the audience for CERs is the notified body/auditor."
"Excellent lessons learned examples."
You have heard about the increased requirements for clinical evaluation with MEDDEV 2.7/1 Rev 4 and the MDR. You may be working on new templates and updating your CERs.
And now come the questions...
- What do these requirements really mean?
- Why are we doing this?
- How are we going to get this all done?
In this webinar, you’ll get the clinical background on new CER requirements from Dr. Dan Lace. Dr. Dan brings a physician’s perspective to unpack concepts like “state of the art” and “sufficient clinical evidence.” He’ll talk about how clinical evidence informs clinical practice, and how evidence-based medicine techniques are applied to CERs.
Then you’ll get insight on the mechanics of putting these concepts into practice from Ryan Kasun, CER Program Manager at R&Q. Ryan will talk about the lessons that R&Q has learned as we’ve walked alongside our clients through the MEDDEV 2.7/1 Rev 4 transition, and he’ll give tips and tricks for the next transition to MDR compliance.
What’s Covered:
- What is evidence-based medicine, and how does it relate to CERs?
- What does “state of the art” mean, and how do I write about it in my CERs?
- What is “sufficient clinical evidence,” and how do I know if I have it?
- What are notified bodies saying?
Key Takeaways:
- Clinical background on regulatory requirements
- Practical tips and guidance for implementation
- Valuable insights from experienced leaders
Who Should View?
This session is designed for medical device manufacturers who market in the EU. Job functions include:
- C-Level Executives
- RA/QA Directors
- Quality Managers
- Regulatory Affairs Managers
- Regulatory Specialists
- Quality Specialists
- Quality Engineers
About the presenters
Daniel A. Lace, MD, CPE, FAAPL
Chief Medical Officer, Leaders in Medicine, Inc.
Dr. Lace’s experience is at the convergence of managed markets, disease and outcome management, and new medical technologies and services. He provides in-depth market analysis for devising payer and purchaser strategies, design and optimization of health management programs and introduction and integration of new products and services.
He provides real-world experience in developing evidence generation strategies to demonstrate value for products and technologies. He provides expertise in market introduction and integration of new medical technologies, products and services to manage healthcare utilization, quality and costs.
Dr. Lace has over 25 years of leadership experience as a healthcare executive across a wide range of managed care, pharmaceutical, device, diagnostic and consulting businesses. He has served as Chief Medical Officer and has held senior leadership positions in global pharmaceutical and device companies, as well as in national managed care organizations.
In addition to being a frequent national speaker and educator on managed care programs and emerging medical technologies, Dr. Lace has authored numerous articles and has served on the Board of Directors, Medical Advisory Boards, Editorial Boards and Expert Panels for multiple healthcare entities.
Ryan Kasun, PMP
CER Program Manager, Regulatory & Quality Solutions (R&Q)
Ryan Kasun is a Program Manager at Regulatory and Quality Solutions (R&Q), an industry-leading regulatory and quality consulting firm that helps medical device and combination product companies bring safe and effective products to market… and keep them there. Ryan has been an R&Q team member for ten years, assisting and leading clients through FDA and international submissions and registrations, quality system implementation and audits, FDA and notified body audit preparation and defense, design and development efforts, design quality assurance projects, manufacturing and quality engineering, and project and program management engagements.
His well-rounded background in medical device regulatory, quality, design, development, manufacturing, and project management allows Ryan to oversee a wide range of efforts, such as managing medical device software development, overseeing R&Q client programs, and growing R&Q’s program for Clinical Evaluation Reports per MEDDEV 2.7/1 Rev. 4 and EU MDR. Ryan has a B.S. in BioMedical Engineering from the Pennsylvania State University, is a certified Project Management Professional (PMP), and is Scrum Master Certified (SMC).
