Regulation (EU) 2017/746

Sistema PJSFC: Director/PDMR Transaction

Retrieved on: 
Wednesday, May 26, 2021

Dissemination of a Regulatory Announcement that contains inside information according to REGULATION (EU) No 596/2014 (MAR), transmitted by EQS Group.

Key Points: 

Dissemination of a Regulatory Announcement that contains inside information according to REGULATION (EU) No 596/2014 (MAR), transmitted by EQS Group.
The issuer is solely responsible for the content of this announcement.

Three Day Course: Comprehensive View of Medical Device Post-Market Regulations and Challenges During COVID-19 - Complaint Handling, MDR Reporting and Recalls (October 21-23, 2021) - ResearchAndMarkets.com

Retrieved on: 
Wednesday, May 26, 2021

The "Comprehensive View of Medical Device Post-Market Regulations and Challenges During COVID-19 - Complaint Handling, MDR Reporting and Recalls" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Comprehensive View of Medical Device Post-Market Regulations and Challenges During COVID-19 - Complaint Handling, MDR Reporting and Recalls" conference has been added to ResearchAndMarkets.com's offering.
  • This course will provide an understanding of MDR & recall compliance and the interrelationship of Complaint Handling, CAPA, and Risk Management processes.
  • Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences.
  • Over 80% of FDA Inspection target observations for lack of compliance in these areas.

Comprehensive View of Medical Device Post-Market Regulations and Challenges During COVID-19: Complaint Handling, MDR Reporting and Recalls - Two Day Course, August 19-20, 2021 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, May 26, 2021

The "Comprehensive View of Medical Device Post-Market Regulations and Challenges During COVID-19 - Complaint Handling, MDR Reporting and Recalls" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Comprehensive View of Medical Device Post-Market Regulations and Challenges During COVID-19 - Complaint Handling, MDR Reporting and Recalls" conference has been added to ResearchAndMarkets.com's offering.
  • This course will provide an understanding of MDR & recall compliance and the interrelationship of Complaint Handling, CAPA, and Risk Management processes.
  • Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences.
  • Over 80% of FDA Inspection target observations for lack of compliance in these areas.

Fix Price Group Ltd. : Notification of PDMR transaction

Retrieved on: 
Tuesday, May 25, 2021

Dissemination of a Regulatory Announcement that contains inside information according to REGULATION (EU) No 596/2014 (MAR), transmitted by EQS Group.

Key Points: 

Dissemination of a Regulatory Announcement that contains inside information according to REGULATION (EU) No 596/2014 (MAR), transmitted by EQS Group.
The issuer is solely responsible for the content of this announcement.

Fix Price Group Ltd. : Notification of PDMR transaction

Retrieved on: 
Monday, May 24, 2021

Dissemination of a Regulatory Announcement that contains inside information according to REGULATION (EU) No 596/2014 (MAR), transmitted by EQS Group.

Key Points: 

Dissemination of a Regulatory Announcement that contains inside information according to REGULATION (EU) No 596/2014 (MAR), transmitted by EQS Group.
The issuer is solely responsible for the content of this announcement.

Celegence Announces Inaugural Medical Device Virtual Summit

Retrieved on: 
Wednesday, May 19, 2021

b'CHICAGO, May 19, 2021 /PRNewswire/ --Celegence, a global provider of regulatory affairs services solutions for the life sciences industry, is pleased to announce that on Tuesday, May 25th, it will host its first annual Medical Device Virtual Summit.

Key Points: 
  • b'CHICAGO, May 19, 2021 /PRNewswire/ --Celegence, a global provider of regulatory affairs services solutions for the life sciences industry, is pleased to announce that on Tuesday, May 25th, it will host its first annual Medical Device Virtual Summit.
  • Those who want to stay up to speed with the medical device industry are encouraged to join, and can visit the Celegence website here to see the full agenda and learn more about the sessions and speakers, and r egister at this link.\n"Continuous learning and network building are critical activities for any medical device professional.
  • Randy Horton, Orthogonal\nThe Medical Device Virtual Summit program will offer access to insights from the medical device industry\'s leading minds.
  • Celegence supports life sciences customers in the areas of EU MDR compliance , regulatory intelligence, RIMS data management, publishing, regulatory labelling , medical writing and compliance toward new regulations for different product portfolios.

Celegence Announces Inaugural Medical Device Virtual Summit

Retrieved on: 
Wednesday, May 19, 2021

b'CHICAGO, May 19, 2021 /PRNewswire/ --Celegence, a global provider of regulatory affairs services solutions for the life sciences industry, is pleased to announce that on Tuesday, May 25th, it will host its first annual Medical Device Virtual Summit.

Key Points: 
  • b'CHICAGO, May 19, 2021 /PRNewswire/ --Celegence, a global provider of regulatory affairs services solutions for the life sciences industry, is pleased to announce that on Tuesday, May 25th, it will host its first annual Medical Device Virtual Summit.
  • Those who want to stay up to speed with the medical device industry are encouraged to join, and can visit the Celegence website here to see the full agenda and learn more about the sessions and speakers, and r egister at this link.\n"Continuous learning and network building are critical activities for any medical device professional.
  • Randy Horton, Orthogonal\nThe Medical Device Virtual Summit program will offer access to insights from the medical device industry\'s leading minds.
  • Celegence supports life sciences customers in the areas of EU MDR compliance , regulatory intelligence, RIMS data management, publishing, regulatory labelling , medical writing and compliance toward new regulations for different product portfolios.

LexisNexis Reed Tech is proud to be recognized by the Dental Trade Alliance as a solution provider for Unique Device Identification (UDI) to U.S. FDA and other Global Health Authorities

Retrieved on: 
Tuesday, May 18, 2021

We are monitoring the progress of global requirements as additional health authorities around the world publish UDI regulations, providing subject-matter expertise to ease the burden on customers.

Key Points: 
  • We are monitoring the progress of global requirements as additional health authorities around the world publish UDI regulations, providing subject-matter expertise to ease the burden on customers.
  • Reed Tech SingleSource for Medical Devices is expanding support for new regions to meet the business-critical needs of manufacturers of dental products and other medical devices.
  • "Complying with current and future UDI requirements of global health authorities is a necessary regulatory task for our membership.
  • We are looking forward to our members utilizing the UDI solution and subject-matter expertise offered by Reed Tech.

Two Day Online Seminar: Fundamentals of EU MDR and IVDR - Level 1, June 24-25, 2021 - ResearchAndMarkets.com

Retrieved on: 
Monday, May 17, 2021

b'The "Fundamentals of EU MDR and IVDR - Level 1" conference has been added to ResearchAndMarkets.com\'s offering.\nThis 2 day seminar will go into the specifics of the European Union Medical Device Regulation (EU MDR) and the In Vitro Diagnostic Device Regulation (IVDR), provide case studies and share lessons learned so your organization can benefit from the mistakes of others.\nWe will review the latest changes to the regulations effective and in force for 2020 and will draw out key developments and key dates with particular emphasis on requirements for US firms shipping materials, parts, and products to the European Union.\nAbility to identify the lifecycle of a device and the requirements of the various stages - premarket, design and development, product realization, and post-market\nUnderstand the impact of the regulation changes on "economic operators" (Articles 11, 13, 14)\nConformity assessment and its relevant changes (Annex IX, Annex X, Annex XI)\nAudit management and Notified Bodies requirements for manufacturers, as well as internal audit impact (Article 51, Annex V111)\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210517005759/en/\n'

Key Points: 
  • b'The "Fundamentals of EU MDR and IVDR - Level 1" conference has been added to ResearchAndMarkets.com\'s offering.\nThis 2 day seminar will go into the specifics of the European Union Medical Device Regulation (EU MDR) and the In Vitro Diagnostic Device Regulation (IVDR), provide case studies and share lessons learned so your organization can benefit from the mistakes of others.\nWe will review the latest changes to the regulations effective and in force for 2020 and will draw out key developments and key dates with particular emphasis on requirements for US firms shipping materials, parts, and products to the European Union.\nAbility to identify the lifecycle of a device and the requirements of the various stages - premarket, design and development, product realization, and post-market\nUnderstand the impact of the regulation changes on "economic operators" (Articles 11, 13, 14)\nConformity assessment and its relevant changes (Annex IX, Annex X, Annex XI)\nAudit management and Notified Bodies requirements for manufacturers, as well as internal audit impact (Article 51, Annex V111)\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210517005759/en/\n'

Lyxor ETF : Lyxor FTSE MIB UCITS ETF - Fund Name change

Retrieved on: 
Tuesday, May 11, 2021

b'Dissemination of a Regulatory Announcement that contains inside information according to REGULATION (EU) No 596/2014 (MAR), transmitted by EQS Group.\nThe issuer is solely responsible for the content of this announcement.\nPlease note that Lyxor will be switching the replication for the below fund:\nOn 12/05/2021 @ the open the below ETF share class will switch to a new benchmark:\n'

Key Points: 
  • b'Dissemination of a Regulatory Announcement that contains inside information according to REGULATION (EU) No 596/2014 (MAR), transmitted by EQS Group.\nThe issuer is solely responsible for the content of this announcement.\nPlease note that Lyxor will be switching the replication for the below fund:\nOn 12/05/2021 @ the open the below ETF share class will switch to a new benchmark:\n'