FDAnews Announces — EU-Medical Device Regulation Compliance Workshops March 17-20, 2020 - Philadelphia, PA

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Devicemakers: It’s time to act and plan. EU-MDR compliance starts in May 2020. Not ready? No worries, just attend this.

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EU-Medical Device Regulation Compliance Workshops
Interactive Workshop Training from FDAnews and Ombu Enterprises
March 17-20, 2020 • Philadelphia, PA
https://www.fdanews.com/eumdrworkshops

Accept our invitation for one, two, three or four productive days of hands-on training.

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

Training kicks off with an introductory 2-day workshop Understanding and Implementing the EU-Medical Device Regulation/In Vitro Diagnostics Regulation on March 17-18. Master the conversion and implement the new MDR including:

  • 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)

Stay an extra day, March 19, to continue training with Post-Market Activities in the EU-MDR — A Detailed Analysis. Untangle one of the most complicated aspects of the new EU-MDR:

  • 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

Need help with EU-MDR auditing? Extend to March 20 with Implementing Effective EU-MDR/IVDR Internal Audit Programs. Get the information needed to integrate a Notified Body (NB) EU-MDR/IVDR type audit into internal quality programs:

  • Conformity assessment paths in the EU-MDR/IVDR based on device class
  • Initial NB auditing requirements in each conformity assessment annex
  • Surveillance NB auditing requirements
  • NB QMS requirements for Annex VII
  • Specific Annex VII areas in the initial audit
  • NB auditor qualifications from Annex VII
  • Mapping the NB audit approach to the medical device auditing program

Space is limited. First come – first served. There’s no time to waste between now and May 2020.

Conference Details:
EU-Medical Device Regulation Compliance Workshops
Interactive Workshop Training from FDAnews and Ombu Enterprises
March 17-20, 2020 • Philadelphia, PA
https://www.fdanews.com/eumdrworkshops

Tuition:
Course #1 Early Bird Pricing: $1,527 (available until Feb. 7, 2020)
Course #1 Regular Pricing: $1,797 (after Feb. 18, 2020)
Course #2 Early Bird Pricing: $767 (available until Feb. 7, 2020)
Course #2 Regular Pricing: $897 (after Feb. 18, 2020)
Course #3 Early Bird Pricing: $767 (available until Feb. 7, 2020)
Course #3 Regular Pricing: $897 (after Feb. 18, 2020)
Significant team discounts are available.

Easy Ways to Register:
Online: https://www.fdanews.com/eumdrworkshops
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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