MDR

European Orthopedic Trauma Devices Market Overview 2019-2026 - Introduction of EU's Medical Device Regulation (MDR) Will Change the Procedures for Introducing New Products Into the Market - ResearchAndMarkets.com

Retrieved on: 
Mercoledì, Maggio 6, 2020
Medical devices, Health, Medical device, MDR, Major trauma, Regulation (EU) No. 305/2011, Medicine, Clinical medicine, Branches of biology

The "Orthopedic Trauma Devices Market Report Suite | Europe | 2019-2026 | MedSuite" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Orthopedic Trauma Devices Market Report Suite | Europe | 2019-2026 | MedSuite" report has been added to ResearchAndMarkets.com's offering.
  • One of the major limiters to the European trauma market is the new Medical Device Regulation (MDR) that will be put into force by the European Union (EU) in May 2020.
  • This will change the procedures for introducing new products into the market, making it a considerably more time intensive and cost-intensive process.
  • Furthermore, the regulations also apply to all products that are currently available on the market.

FDAnews Announces -- Sustained Medical Device Regulation Compliance: Ensure Your Regulatory Processes and Tools are Fully Optimized, Sponsored by Instem, Webinar, May 20

Retrieved on: 
Lunedì, Maggio 4, 2020
MDR, Medical device, Regulatory compliance, Regulatory agency

FALLS CHURCH, Va., May 4, 2020 /PRNewswire-PRWeb/ -- Sustained Medical Device Regulation Compliance:

Key Points: 
  • FALLS CHURCH, Va., May 4, 2020 /PRNewswire-PRWeb/ -- Sustained Medical Device Regulation Compliance:
    Even though the European Commission will likely postpone the date of application for the European Medical Device Regulation (EU-MDR), the medical device industry must not curtail compliance readiness activities.
  • Implementation of EU-MDR and IVDR will exponentially increase the volume and velocity of data that requires regulatory operations support.
  • Now is the time to challenge the status quo and leverage technology solutions to improve the efficiency of regulatory operations information management.
  • Attend this free webinar sponsored by Instem and understand how to optimize processes and tools to ensure that regulatory operations meet global regulatory compliance.

CenterWatch Announces -- Medical Device Trials in the EU: A Guide to the New EU MDR and Revised ISO 14155 Management Report

Retrieved on: 
Martedì, Marzo 24, 2020
Health, Clinical research, Pharmaceutical industry, ISO 14155, Medical research, MDR, Medical device, Clinical trial

FALLS CHURCH, Va., March 24, 2020 /PRNewswire-PRWeb/ --The world of clinical trials is changing rapidly, with the EU MDR's new and more complex rules and the forthcoming ISO/DIS 14155:2018 updates.

Key Points: 
  • FALLS CHURCH, Va., March 24, 2020 /PRNewswire-PRWeb/ --The world of clinical trials is changing rapidly, with the EU MDR's new and more complex rules and the forthcoming ISO/DIS 14155:2018 updates.
  • The Medical Device Trials in the EU: A Guide to the New EU MDR and Revised ISO 14155 management report provides insight into the EU MDR's extensive requirements for documenting, conducting and reporting clinical trials, including which devices are exempt.
  • Manufacturers of non-exempt devices must set up a clinical trials program using both EU MDR and ISO/DIS 14155:2018.
  • Medical Device Trials in the EU:

FDAnews Announces -- EU-MDR: Are You Ready? Part II: Tips for Assessing Your Readiness Prior to Notified Body Review Webinar, Mar. 26, 2020

Retrieved on: 
Giovedì, Marzo 12, 2020
Pharmaceuticals policy, Food and Drug Administration, Articles, Health, Barcodes, MDR, Medical device, Unique Device Identification, Traceability, UDI

How current is the product labeling on one's website?

Key Points: 
  • How current is the product labeling on one's website?
  • Is your unique device identification (UDI) uploaded to the European database on medical devices (EUDAMED)?
  • The new EU-MDR is designed to increase safety by making products more readily traceable and one will need to have the right strategies in place.
  • This webinar is part two of a three-part online series on EU-MDR readiness.

FDAnews Announces --17th Annual Medical Device Quality Congress April 20-22, 2020 - Bethesda, MD

Retrieved on: 
Mercoledì, Gennaio 22, 2020
Medical device, MDR, EU medical device regulation, CE marking, Regulatory compliance, Food and Drug Administration, Articles, Medical device reporting, Public law

Attend the premier event for device quality and compliance professionals: the 17th Annual Medical Device Quality Congress.

Key Points: 
  • Attend the premier event for device quality and compliance professionals: the 17th Annual Medical Device Quality Congress.
  • A special focus on the new EU Medical Device Regulation (EU-MDR) will ensure compliance in Europe.
  • With the Medical Device Quality Congress taking place weeks before the May 2020 EU-MDR deadline, attendees will easily fine-tune plans and strengthen product positions in advance of these sweeping changes.
  • This is 2020's most important event for devicemakers: the 17th Annual Medical Device Quality Congress.

Introduction to the Medical Device Regulation Seminar: London, United Kingdom - November 11-13, 2020 - ResearchAndMarkets.com

Retrieved on: 
Lunedì, Dicembre 16, 2019
Education, Training, Health, Medical devices, Medical device, MDR

The "An Introduction to the Medical Device Regulation" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "An Introduction to the Medical Device Regulation" conference has been added to ResearchAndMarkets.com's offering.
  • This seminar provides a detailed introduction to the European Medical Device Regulation (MDR).
  • This event will be of particular interest to all personnel who are new to the medical device industry, all those who intend to place a medical device on the market and anyone who requires an overview of the medical device sector.
  • What is a medical device?

Three Day Introduction to the European Medical Device Regulation Seminar - London, United Kingdom - May 13-15, 2020

Retrieved on: 
Lunedì, Dicembre 2, 2019
Medical device, MDR

DUBLIN, Dec. 2, 2019 /PRNewswire/ -- The "An Introduction to the Medical Device Regulation" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Dec. 2, 2019 /PRNewswire/ -- The "An Introduction to the Medical Device Regulation" conference has been added to ResearchAndMarkets.com's offering.
  • This seminar provides a detailed introduction to the European Medical Device Regulation (MDR).
  • This event will be of particular interest to all personnel who are new to the medical device industry, all those who intend to place a medical device on the market and anyone who requires an overview of the medical device sector.
  • What is a medical device?

Three Day Seminar: Introduction to the Medical Device Regulation (London, United Kingdom - May 13-15, 2020) - ResearchAndMarkets.com

Retrieved on: 
Lunedì, Dicembre 2, 2019
Education, Training, Health, Medical devices, Medical device, MDR

The "An Introduction to the Medical Device Regulation" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "An Introduction to the Medical Device Regulation" conference has been added to ResearchAndMarkets.com's offering.
  • This seminar provides a detailed introduction to the European Medical Device Regulation (MDR).
  • This event will be of particular interest to all personnel who are new to the medical device industry, all those who intend to place a medical device on the market and anyone who requires an overview of the medical device sector.
  • What is a medical device?

Three Day Course: Introduction to the European Medical Device Regulation - London, United Kingdom - November 11-13, 2019

Retrieved on: 
Martedì, Ottobre 15, 2019
Medical device, MDR

DUBLIN, Oct. 15, 2019 /PRNewswire/ -- The "An Introduction to the Medical Device Regulation" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Oct. 15, 2019 /PRNewswire/ -- The "An Introduction to the Medical Device Regulation" conference has been added to ResearchAndMarkets.com's offering.
  • This seminar provides a detailed introduction to the European Medical Device Regulation (MDR).
  • This event will be of particular interest to all personnel who are new to the medical device industry, all those who intend to place a medical device on the market and anyone who requires an overview of the medical device sector.
  • What is a medical device?

An Introduction to the European Medical Device Regulation (London, United Kingdom - November 11-13, 2019) - ResearchAndMarkets.com

Retrieved on: 
Martedì, Ottobre 15, 2019
Legal, Professional services, Health, Medical devices, Medical device, MDR

The "An Introduction to the Medical Device Regulation" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "An Introduction to the Medical Device Regulation" conference has been added to ResearchAndMarkets.com's offering.
  • This seminar provides a detailed introduction to the European Medical Device Regulation (MDR).
  • This event will be of particular interest to all personnel who are new to the medical device industry, all those who intend to place a medical device on the market and anyone who requires an overview of the medical device sector.
  • What is a medical device?