Course I – Understanding and Implementing the EU-MDR/IVDR: Sept. 10-11, 2019
Course II – Implementing Effective EU-MDR/IVDR Internal Audit Programs: Sept. 12, 2019
Your legacy products marketed in the EU are at serious risk unless you act now. You will be out of the market in May 2020 unless you implement some portions of the EU-MDR. At best, this is stopgap measure that will give you a little extra time for a full implementation.
The new EU regulations (MDR and IVDR) create detailed, complicated, and confusing requirements. They eliminate the current directives and require manufacturers to start over.
The new regulations include many different terms, many new processes (management of economic operators, trend analysis, etc.), and major changes to older process (clinical evaluation).
The implementation timelines are very short. The EU-IVDR has a more time, but also more new and unfamiliar requirements.
Because of similarities in the regulations the workshop discusses both regulations. It includes sections on the major differences as needed to provide a comprehensive view. In addition, the course material includes checklists and other tools that are specific to the individual regulations.
Mark your calendar for some productive days of hands-on training with Dan O’Leary of Ombu Enterprises, one of FDA News’ most in-demand trainers. Over the course of two days (Sept. 10-11), you will understand how to implement the new regulations including:
- The new classification system (how to apply the system)
- Conformity assessment paths (how paths apply to specific devices)
- Annex I requirements
- Technical documentation requirements (how to document compliance)
- Unique Device Identification (EU approach)
- Notified Body (its role)
- And much more!
SPECIAL WORKSHOP FEATURE
Bring your own products for custom treatment! Bring examples of your devices to use in some of the exercises.
Special Third-Day Add-On:
Implementing Effective EU-MDR/IVDR Internal Audit Programs
With just one additional day, you will learn to conduct effective internal audits of the new EU-MDR/IVDR requirements, including good audit practices, an understanding of the Notified Body’s (NB) audit expectations, and integrating an NB EU-MDR/IVDR type audit into your internal quality program. Preparing for the NB audit, knowing what to expect, is an important factor for success.
During the course of this hands-on, interactive workshop, you will:
- Understand the conformity assessment paths in the EU-MDR/IVDR based on class
- Understand the initial NB auditing requirements in each conformity assessment annex
- Review the surveillance NB auditing requirements
- Understand the NB QMS requirements for Annex VII
- Learn the specific Annex VII areas in the initial audit
- Learn the NB auditor qualifications from Annex VII
- Learn how to map the NB audit approach to an internal quality audit program
This add-on workshop assumes a basic familiarity with the EU-MDR/IVDR and with quality auditing. Attending the previous day’s workshop (Sept. 10-11) is recommended but not required to attend this (Sept. 12) workshop.
If you do business in the EU, this add-on cannot be missed. Space is limited, so… Reserve your seat TODAY.