WCG FDAnews
FALLS CHURCH, Va. (PRWEB) September 08, 2020
EU-Medical Device Regulation and In Vitro Diagnostics Regulation Compliance: Virtual Workshop Series
Presented by FDAnews and Ombu Enterprises
Tuesday, Sept. 29, 2020: EU-MDR Implementation
Tuesday, Oct. 27, 2020: EU-IVDR Implementation
Wednesday, Nov. 4, 2020: Post-Market Activities for the EU-MDR and EU-ICDR
Tuesday, Nov. 10, 2020: Auditing EU-MDR and EU-IVDR Implementation
All sessions are held from 10:00 a.m.-4:30 p.m. ET.
https://www.fdanews.com/eumdrworkshopseries
Join us for one, two, three or four productive days of hands-on virtual 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 2021 set date. The transition is one complicated set of rules!
With one extension already granted, any organization selling devices in the region now needs to be ready by the May 2021 set date. There’s little time to spare to get the processes up to par. There is still hope to align manufacturing with these expectations. While it may be impossible to fully meet the EU-MDR or EU-IVDR, learn how to remain compliant.
Mark the calendar for one, two, three, or four productive, exciting days of hands-on sessions with Dan O’Leary, a renowned regulatory and training specialist. Receive detailed checklists on device classifications, the application of Annex I, and internal quality audits, along with a workbook on UDI implementation.
We’ll begin the workshop with a session on EU-MDR Implementation on Tuesday, September 29 from 10:00 a.m. to 4:30 p.m. Attendees will have the opportunity to dig deep into EU-MDR requirements and how a team can move toward full implementation. We’ll cover:
- Article 120: Transitioning into the EU-MDR through timeline concerns
- QMS Implementation: Article 10(9) requirements and other QMS elements
- Device Implementation: Annexes I, II, III, VIII and Article 52
- Notified Body Interactions: Conformity assessment, notified body technical document review, and notified body on-site audits
Continue with us on Tuesday, October 27, and learn about EU-IVDR Implementation. While the date for these requirements isn’t until May 2022, the time to get started on these changes is now. Join us for this session, and we’ll cover:
- Article 110: Transitioning into the EU-IVDR through timeline concerns
- QMS Implementation: Article 10(8) requirements and QMS elements
- Device Implementation: Annex I, II, III, VIII and Article 48
- Notified Body Interactions: Conformity assessment, notified body technical document review, and notified body on-site audits
After the knowledge gained from the first two sessions (or if one is already an expert), join us for our third session on Post-Market Activities for the EU-MDR and EU-IVDR on Wednesday, November 4. We’ll discuss:
- Pre-Market Considerations: Clinical evaluation and performance, risk management and determination, and pre-market indicators and thresholds
- Market Surveillance: Market and post-market surveillance; clinical follow-up
- Post-Market Performance Follow-Up and SSCP
- Vigilance and Trend Analysis
In our fourth and final session, we’ll discuss Auditing EU-MDR and EU-IVDR Implementation on Tuesday, November 10. We’ll share insights on the importance of good project management methods, including those around:
- Internal Audit Programming: ISO 19011:2018 and 13485:2016
- Conformity Assessment Paths and Device-Specific Areas: QMS and RMS; Annex I, II, and III
- Applications to Notifying Bodies
- Notifying Body Approach to Audits
The deadlines for these new regulations are approaching quickly. Don’t miss this chance to gain expert advice on what can become a complicated, difficult and long process —and do it all from the comfort of one’s own home.
Virtual Conference Details:
EU-Medical Device Regulation and In Vitro Diagnostics Regulation Compliance: Virtual Workshop Series
Presented by FDAnews and Ombu Enterprises
Tuesday, Sept. 29, 2020: EU-MDR Implementation
Tuesday, Oct. 27, 2020: EU-IVDR Implementation
Wednesday, Nov. 4, 2020: Post-Market Activities for the EU-MDR and EU-ICDR
Tuesday, Nov. 10, 2020: Auditing EU-MDR and EU-IVDR Implementation
All sessions are held from 10:00 a.m.-4:30 p.m. ET.
https://www.fdanews.com/eumdrworkshopseries
Tuition:
Part I: $587 per site
Part II: $587 per site
Part III: $587 per site
Part IV: $587 per site
Complete Series: $1,672
Easy Ways to Register:
Online: https://www.fdanews.com/eumdrworkshopseries
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