Regulation (EU) 2017/745

Aker ASA: Reporting of transactions made by persons discharging managerial responsibilities

Retrieved on: 
Wednesday, November 15, 2023
Public affairs, Disclosure, Regulation, ASA, NOK, MAR, Security (finance), Regulation (EU) 2017/745, Aker ASA

OSLO, Norway, Nov. 15, 2023 /PRNewswire/ -- Atle Kigen, Head of Media Relations and Public Affairs in Aker ASA has sold 6,000 shares in Aker ASA, at a price of NOK 689.32 per share.

Key Points: 
  • OSLO, Norway, Nov. 15, 2023 /PRNewswire/ -- Atle Kigen, Head of Media Relations and Public Affairs in Aker ASA has sold 6,000 shares in Aker ASA, at a price of NOK 689.32 per share.
  • Following the transaction, Atle Kigen holds 2,770 of shares in Aker ASA.
  • Please see the attached primary insider notifications for more details.
  • This information is subject to the disclosure requirements pursuant to Regulation EU 596/2014 (MAR) article 19 number 3 and the Norwegian Securities Trading Act section 5-12.

Irdeto partners with confinis to launch the first cybersecurity assessment tool in the medical devices industry

Retrieved on: 
Tuesday, July 6, 2021
Regulation (EU) 2017/746, Data security, Medical device, Regulation (EU) 2017/745, Cyberwarfare, Technology, Computer security, Medtech, Articles, Common specifications

As part of the partnership, Irdeto and confinis will launch a web-based assessment tool enabling medical device providers to examine their cybersecurity and regulatory preparedness under the European Medical Device Regulation (MDR) and the European In Vitro Diagnostic Medical Device Regulation (IVDR).

Key Points: 
  • As part of the partnership, Irdeto and confinis will launch a web-based assessment tool enabling medical device providers to examine their cybersecurity and regulatory preparedness under the European Medical Device Regulation (MDR) and the European In Vitro Diagnostic Medical Device Regulation (IVDR).
  • Protection of connected medical devices as well as the information of providers and patients that use them is essential.
  • Together, we are making the medical devices industry stronger and protecting patients from cyberattacks that could negatively affect their health and wellbeing."
  • "The combined expertise of confinis and Irdeto will bring unparalleled cybersecurity and regulatory capabilities to medtech customers.

Global Ophthalmic Devices, Diagnostics and Surgical Equipment Market (2021 to 2026) - Featuring Alcon, Carl Zeiss and Hoya Among Others - ResearchAndMarkets.com

Retrieved on: 
Wednesday, June 23, 2021
Medical devices, Health, Medical device, Regulation (EU) 2017/745

The global population will continue to grow and age.

Key Points: 
  • The global population will continue to grow and age.
  • This suggests a steady market path for ophthalmic diagnostics, devices and surgical equipment throughout the next several decades.
  • Several significant trends continue to influence this market.
  • Trends covered in this report include the following:
    Government regulation for medical devices.

Implantica strengthens the Management team with new VP QA & RA

Retrieved on: 
Monday, June 21, 2021
Occupations, Regulatory affairs, Biomedical engineering, Regulation (EU) 2017/745, Medical device, Rayner, Articles, Economy

With over 20 years of regulatory affairs experience, she has obtained approvals and access to new markets in over 120 countries.

Key Points: 
  • With over 20 years of regulatory affairs experience, she has obtained approvals and access to new markets in over 120 countries.
  • Juliette Cook is also an expert in EU Medical Device Regulation (MDR), regularly presenting and teaching the subject at industry events and conferences.
  • Prior to Cochlear, Juliette Cook was Director of Quality, Clinical & Regulatory Affairs at Rayner Intraocular Lenses Ltd. where she established the QA & RA department.
  • in Biomedical Engineering from University of Durham and obtained a Ph.D. in Materials/Mechanical Engineering from the University of Exeter.

DEARhealth becomes one of the world's first companies to obtain CE-marking according to new European Union Medical Device Regulation (MDR)

Retrieved on: 
Wednesday, June 9, 2021
Regulation, Articles, Medical device, Quality management, Regulation (EU) 2017/745, Medical software, Evaluation, Conformance testing, Regulation (EU) 2017/746, Regulation (EU) No. 305/2011, MDR, Quality management system

The CE-mark allows DEARhealth to market its medical software commercially in the European Union.

Key Points: 
  • The CE-mark allows DEARhealth to market its medical software commercially in the European Union.
  • CE-marking according to MDR assures health systems and pharmaceutical companies that a software as a medical device complies to European Union regulation and meets a high standard of quality and safety requirements.
  • "Our partnersin both the US and Europecan be confident that we design and manufacture our medical device software under high standards of quality and safety.
  • Following a successful conformity assessment, including an audit of the quality management system, DEARhealth is among the first 250 manufacturers to obtain CE-marking according to MDR for their medical device software.

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
FDA, Health, Medical devices, Regulation (EU) 2017/745, Food and Drug Administration, Medical device, Regulation (EU) 2017/746, Health, Medicine, Pharmaceuticals policy

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
Legal, Professional services, Health, Other Health, Regulation (EU) 2017/745, Food and Drug Administration, Medical device, Regulation (EU) 2017/746, Health, Medicine, Pharmaceuticals policy

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.

Celegence Announces Inaugural Medical Device Virtual Summit

Retrieved on: 
Wednesday, May 19, 2021
Articles, Regulation (EU) 2017/745, Regulatory affairs, Regulation (EU) 2017/746, Medical device, Medical writing, MDR, Human activities

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
Articles, Regulation (EU) 2017/745, Regulatory affairs, Regulation (EU) 2017/746, Medical device, Medical writing, MDR, Human activities

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
Legal research, Reed Tech, Medical device, Regulation (EU) 2017/745, Law, Regulation (EU) 2017/746, Articles

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.