Navigation Links
FDAnews Announces — 1 Week Until EU-Medical Device Regulation Compliance Workshops March 17-20, 2020 - Philadelphia, PA

EU-Medical Device Regulation Compliance Workshops
Interactive Workshop Training from FDAnews and Ombu Enterprises
March 17-20, 2020 • Philadelphia, PA

EU-Medical Device Regulation Compliance Workshops starts in one week.

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.

Reminder: EU-Medical Device Regulation Compliance Workshops starts in one week.

Conference Details:
EU-Medical Device Regulation Compliance Workshops
Interactive Workshop Training from FDAnews and Ombu Enterprises
March 17-20, 2020 • Philadelphia, PA

Course #1 Regular Pricing: $1,797
Course #2 Regular Pricing: $897
Course #3 Regular Pricing: $897
Significant team discounts are available.

Easy Ways to Register:
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.

Read the full story at

Source: PRWeb
Copyright©2020 Vocus, Inc.
All rights reserved

Related medicine news :

1. FDAnews Announces — 1 Week Until FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers Workshop March 17-18, 2020, Philadelphia, PA
2. FDAnews Announces — Healthcare Innovation and FDA Regulation: Former FDA Commissioner Explains Growing Opportunities for Biomedical Products Webinar, Mar. 19, 2020
3. FDAnews Announces — Pharmacy Compounding Regulation: FDA’s Latest Guidance, Compliance & Enforcement Activities Webinar, Feb. 18, 2020
4. FDAnews/CenterWatch Announces — Real World Evidence and Data: A Tufts Study of 30 Pharma Companies Webinar January 23, 2020
5. FDAnews Announces — Postmarket Problems for Medical Devices: The Path to Resolution Workshop Feb. 19-20, 2020 - Atlanta, GA
6. FDAnews Announces — Understanding UDI in EU Device Regulations Webinar, Nov. 21, 2019
7. FDAnews Announces — 1 Week Until Conducting Advanced Root Cause Analysis and CAPA Investigations: Critical Thinking Skills and Innovative Techniques Nov. 13-14
8. FDAnews Announces — Early Bird Pricing Ends on Nov. 12, Building a World-Class Advertising and Promotion Review Program Dec. 10-11, 2019 Miami, FL
9. FDAnews Announces — Labeling for Prescription Drugs, Biologics and Combination Products:Complying with FDA’s Most Recent IFU Guidance Webinar, Oct. 29, 2019
10. FDAnews Announces — Medical Device Nonconforming Audit Findings: Corrective Action That’s Right for Your Company Webinar, Oct. 15, 2019
11. FDAnews Announces — 510(k) Change Analysis: Make the Guidance Documents Work for You Webinar, August 22, 2019
Post Your Comments:
(Date:3/30/2021)... , ... March 29, 2021 , ... ... the 21st Century , A Virtual Workshop Presented by WCG FDAnews and Cerulean ... 4:30 pm EDT, , Are one’s SOPs written for the ...
(Date:3/30/2021)... ... March 29, 2021 , ... According to data released ... reproductive age (13-44) in need of publicly funded contraception live in counties impacted by ... Colorado’s 64 counties have lost some of their Title X resources. , The ...
(Date:3/30/2021)... ... March 29, 2021 , ... Health Literacy Innovations (HLI), a ... confusion due to low health literacy today announces a new partnership with the ... work with ACAP’s member Safety Net Health Plans, those that provide comprehensive health ...
(Date:3/30/2021)... ... ... Dr. Colin Campbell is proud to announce the 1 year anniversary in their new state ... internal medicine and is a primary care specialist who has been practicing for 23 years. ... keep South Jersey healthy one patient at a time. , “Over the past year, Dr. ...
(Date:3/30/2021)... ... March 30, 2021 , ... The COVID-19 ... and survivors; their families; and their caregivers. Crossroads4Hope is addressing the needs of ... emotional support system, MyGo2Support, which meets needs of people impacted by cancer, no ...
Breaking Medicine News(10 mins):
(Date:3/30/2021)... ... March 29, 2021 , ... The University of Texas Health Science Center ... San Antonio Multispecialty and Research Hospital, a destination center for research and treatment of ... In a nod to the COVID-19 pandemic, the ceremony was held virtually. , William ...
(Date:3/30/2021)... ... March 29, 2021 , ... Iora Health ... primary care, has partnered with Devoted Health , one of the fastest-growing ... across Maricopa County and provides seniors with the highest-quality care and experience possible, ...
(Date:3/30/2021)... CITY (PRWEB) , ... March 29, 2021 , ... ... has joined the Vaccine Credential Initiative (VCI), a group bringing together leading health ... record of vaccination status, based on open, interoperable standards. By joining the VCI ...
Breaking Medicine Technology: