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FALLS CHURCH, Va., April 26, 2019 /PRNewswire-PRWeb/ -- EU-Medical Device Regulation and In-vitro Diagnostic Compliance Workshop Interactive Workshop Training from FDAnews and Ombu Enterprises June 10-12, 2019 Waltham, MA (Boston) https://www.fdanews.com/eumdreg
Early bird pricing for EU-Medical Device Regulation and In-vitro Diagnostic Compliance Workshop ends on May 3.
Understanding and Implementing the EU-MDR & EU-IVDR: June 10-11, 2019 Post-Market Activities in the EU-MDR A Detailed Analysis: June 12, 2019
The EU-MDR and IVDR compliance clocks are ticking daily. Many devicemakers still aren't ready to meet the Dates of Application. The new regulations are very complicated sets of rules!
The new regulations are a handful. They will change the way one does business in the European Union!
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:
Stay one more day. Participate in a workshop untangling one of the most complicated aspects of the new EU-MDR post-market activities one will discover:
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.
Early bird pricing ends on Friday May 3.
Who Should Attend:
Tuition: Early Bird Pricing Course I (Days 1&2): $1,597 (available until May 3, 2019) Regular Pricing Course I (Days 1&2): $1,797 (after May 3, 2019) Early Bird Pricing Course II (Day 3): $797 (available until May 3, 2019) Regular Pricing Course II (Day 3): $897 (after May 3, 2019) Early Bird Pricing Course I & II: $1,947 (available until May 3, 2019) Regular Pricing Course I & II: $2,197 (available until May 3, 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.
SOURCE FDAnews
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Early bird pricing for EU-Medical Device Regulation and In-vitro Diagnostic Compliance Workshop ends on May 3.
Understanding and Implementing the EU-MDR & EU-IVDR: June 10-11, 2019 Post-Market Activities in the EU-MDR A Detailed Analysis: June 12, 2019
The EU-MDR and IVDR compliance clocks are ticking daily. Many devicemakers still aren't ready to meet the Dates of Application. The new regulations are very complicated sets of rules!
- Entire product portfolio will need re-approval
- Standards such as EN ISO 13485:2016, changed once already, will change again to align with the new regulations
- There is a new version of EN ISO 14917 planned for 2019
- Turnaround time for serious incident reporting will drop from 30 to only 15 days
The new regulations are a handful. They will change the way one does business in the European Union!
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)
- The new IVDR classification system (how to apply the system)
- Conformity assessment paths (how paths apply to specific devices)
- Annex I requirements
- Technical documentation requirements (how to document compliance)
- Unique Device Identification (EU approach)
- Notified Body (its role)
- And much more!
Stay one more day. Participate in a workshop untangling one of the most complicated aspects of the new EU-MDR post-market activities one 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!
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.
Early bird pricing ends on Friday May 3.
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
Tuition: Early Bird Pricing Course I (Days 1&2): $1,597 (available until May 3, 2019) Regular Pricing Course I (Days 1&2): $1,797 (after May 3, 2019) Early Bird Pricing Course II (Day 3): $797 (available until May 3, 2019) Regular Pricing Course II (Day 3): $897 (after May 3, 2019) Early Bird Pricing Course I & II: $1,947 (available until May 3, 2019) Regular Pricing Course I & II: $2,197 (available until May 3, 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.
SOURCE FDAnews