FALLS CHURCH, Va. (PRWEB) June 29, 2018
Devicemakers face an array of tough new rules as the EU phases in the new Medical Device Directive (MDR). These rules will change how they do business everywhere in the world.
- The entire product portfolio will need re-approval
- Standards such as the ISO 13485:2016, changed once already, will change again to align with the new MDR
- Turnaround time for incident reporting will drop from 30 to only 15 days
This barely scratches the surface. The MDR, which replaces the existing Medical Device Directive (MDD), is 175 pages (vs. 60) of new provisions, changes to existing ones, inclusions and exclusions. And confusion abounds. For example the Rules for accrediting Notified Bodies (NB) aren’t even final yet.
Devicemakers may think they have lots of time to comply but they don’t. Fewer than two years remain. Here’s what to do..
Mark the calendar for an intense hands-on training session in Philadelphia, Tuesday-Thursday, Sept. 10-12. Over the course of two days understanding and implementing the new MDR, plus a third add-on day focusing on post-market activities, attendees will discover:
- The new MDR classification system: How to apply it
- Conformity assessment paths: How they apply to specific devices
- Annex I requirements: How to document compliance
- Technical documentation requirements in Annex I and Annex II
- Unique Device Identification: The EU approach
- Economic operators and their relationship to manufacturers
- Notified Body: What it is, what it does
- And MUCH more!
Attendees will receive detailed checklists to help classify devices, apply Annex I requirements and conduct internal quality audits, as well as:
- A map from the MDD Annex I to the MDR Annex I
- A workbook of device attributes used for UDI implementation
Add a third day and participate in this all-day workshop untangling one of the most complicated aspects of the new EU-MDR: Post-market activities. Attendees will discover:
- Which devices (by class and other attributes) require any specific activity
- Developing a plan for each activity
- Developing a report for each activity
- Understanding frequency and distribution of each report
- Adverse events: Understanding classification and reporting
- And MUCH more!
This add-on workshop assumes a basic familiarity with the EU-MDR. Course I is recommended but not required.
The workshop leader, Dan O’Leary of Ombu Enterprises LLC, is a favorite of thousands of conference attendees for his ability to simplify the most complex device-related topics.
Who Should Attend:
Here are just a few of the many executives who will benefit:
- Quality Managers/Engineers
- Risk Managers
- Regulatory Affairs
- Design Engineers
- Supply Chain Managers
- Production Managers/Engineers
- Document Control Specialists
- Marketing Managers
- Clinical Managers
- Clinical Evaluation Specialists
- Export Compliance Managers
Early Bird Registration (until Aug. 17, 2018):
- Complete Conference: $1,947
- Course 1: $1,597
- Course 2: $797
- Complete Conference: $2,197
- Course 1: $1,797
- Course 2: $897
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