FDAnews Announces — EU-Medical Device Regulation Compliance Workshops June 10-12, 2019 Boston, MA

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Devicemakers: It’s time to act and plan. EU-MDR compliance starts in May 2020. Not ready? No worries! Just read this …

WCG Market Intelligence & Insights

WCG Market Intelligence & Insights

EU-Medical Device Regulation Compliance Workshops
**Interactive Workshop Training from FDAnews and Ombu Enterprises**
June 10-12, 2019
Waltham, MA (Boston)

Understanding and Implementing the EU-MDR: June 10-11, 2019
Post-Market Activities in the EU-MDR — A Detailed Analysis: June 12, 2019

The EU-MDR compliance clock is ticking… daily. Many devicemakers still aren’t ready for May 2020 set date. The transition is one complicated set of rules!

  • Entire product portfolios 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

And that’s just for openers.

The new EU-MDR is a handful. It will change how one does business everywhere in the world.

Here’s how we can help…

Mark the calendar for two, or three, productive days of hands-on training with Dan O’Leary of Ombu Enterprises, one of FDAnews’ most in-demand trainers. Over the course of two days (June 10-11), attendees will understand the conversion and implement the new MDR:

  • The new MDR classification system (how to apply the system)
  • Conformity assessment paths (how paths apply to specific devices)
  • Annex I requirements (how to document compliance)
  • Technical documentation requirements
  • Unique Device Identification (EU approach)
  • Notified Body (its role)
  • And much more!

Special Third-Day Add-On:
Post-Market Activities in the EU-MDR — A Detailed Analysis

Stay one more day. Participate in a 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
  • How to develop a plan and report for each activity
  • Understanding frequency and distribution of each report
  • Adverse events classification and reporting
  • And much more!

This add-on workshop assumes a basic familiarity with the EU-MDR. Attending the previous day’s workshop (June 10-11) is recommended but not required to attend this (June 12) day.

The first EU-MDR compliance deadline falls in May 2020, less than a year after this workshop. There’s no time to waste and space is limited. Reserve a seat today.

Who Should Attend:

  • 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

Webinar Details:
EU-Medical Device Regulation Compliance Workshops
**Interactive Workshop Training from FDAnews and Ombu Enterprises**
June 10-12, 2019
Waltham, MA (Boston)

Early Bird Pricing: $1,597 (available until April 9, 2019)
Regular Pricing: $1,797 (after April 9, 2019)
Significant team discounts are available.

Easy Ways to Register:
Online: https://www.fdanews.com/eumdreg
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative,
and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
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