FDAnews Announces — Early Bird Pricing Ends on Aug. 9, EU-Medical Device Regulation/ In Vitro Diagnostics Regulation Compliance Workshops Sept. 10-12, 2019

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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/ In Vitro Diagnostics Regulation Compliance Workshops
**Interactive Workshop Training from FDAnews and Ombu Enterprises**
Sept. 10-12, 2019 • Philadelphia, PA
https://www.fdanews.com/eumdrivdr

Early bird pricing for EU-Medical Device Regulation/ In Vitro Diagnostics Regulation Compliance Workshops ends on Aug. 9.

Understanding and Implementing the EU-MDR/IVDR: Sept. 10-11, 2019
Implementing Effective EU-MDR/IVDR Internal Audit Programs: Sept. 12, 2019

The EU-MDR compliance clock is ticking… daily. Legacy products marketed in the EU are at serious risk unless organizations act now. Many devicemakers still aren’t ready for May 2020 set date. The transition is one complicated set of rules!

  • 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

And that’s just for openers.

The new EU-MDR is a handful. It will change how organizations do 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 (Sept. 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:
Implementing Effective EU-MDR/IVDR Internal Audit Programs

If ones organization does any business in the EU, this one-day workshop will be vital. Attendees will get the information you need to integrate a Notified Body (NB) EU-MDR/IVDR type audit into an internal quality program. Attendees will:

  • Understand the conformity assessment paths in the EU-MDR/IVDR based on device 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 the medical device auditing 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) day.

Gain the direct, hands-on training to need to comply with regulators’ requirements and expectations. Space is limited…

Early bird pricing ends on Friday, August 9.

Webinar Details:
EU-Medical Device Regulation/ In Vitro Diagnostics Regulation Compliance Workshops
**Interactive Workshop Training from FDAnews and Ombu Enterprises**
Sept. 10-12, 2019 • Philadelphia, PA
https://www.fdanews.com/eumdrivdr

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

Easy Ways to Register:
Online: https://www.fdanews.com/eumdrivdr
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
FDAnews
703-538-7600
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