• Medical Devices
  • News

Medical Devices and EU 2017/745, exclusive interview

The legislation governing medical devices (MDs) having largely demonstrated its ineffectiveness during the PIP implant scandal, the new 2017/745 regulation reinforces patient safety by introducing clinical evaluation of the MD, post-market surveillance and a unique identification system for better traceability is more transparency. Stéphane ANCEL, Commercial Director at Ackomas, presents Ackomas' approach and its innovative…

ackomas

For ackomas, the 17 Jan 2024

Reading time: 1 min.

  • News

Ackomas and Nexialist co-present a webinar focusing on Eudamed

Nexialist organized a webinar dedicated to Eudamed, the European medical device database. The implementation of European regulations EU2017/745 MDR and EU2017/746 IVDR continues to raise questions for medical device manufacturers. For this reason, Nexialist, the consulting firm specializing in regulatory intelligence and compliance for healthcare products, recently organized a webinar on the subject and invited…

ackomas

For ackomas, the 15 Nov 2023

Reading time: 1 min.

  • Medical Devices
  • News

Published in DeviceMed France

Published at the beginning of September, DeviceMed France's latest issue looks at Eudamed compliance, the means to achieve it and the urgent need to implement suitable tools, featuring KOA software, a SaaS solution developed by Ackomas. Happy reading! Download the article

ackomas

For ackomas, the 12 Sep 2023

Reading time: 1 min.

  • Medical Devices

Eudamed registration, creation of the Master UDI-DI

European regulations require a unique identification system for medical devices (UDI) to improve and facilitate traceability. After launching a major consultation process last spring, the European Commission has just approved the creation of a Master UDI-DI for certain so-called "highly individualized" medical devices. The medical devices, such as contact lenses, which were included in the…

ackomas

For ackomas, the 11 Jul 2023

Reading time: 2 min.

  • Medical Devices
  • News

Webinar – Practical questions about Eudamed compliance

The timetable for the implementation of regulations EU 2017/745 and EU 2017/746 continues to unfold, with an important next step: the operational qualification of the EUDAMED database. This step, which makes mandatory the publication of data on Medical Devices and In Vitro Diagnostics, still raises many questions among industry professionals. Ackomas is organizing a webinar…

ackomas

For ackomas, the 06 Jul 2023

Reading time: 2 min.

  • News

Ackomas participates at Medi’nov Connection

On May 1st and June 1st, Ackomas will exhibit at the Medi'nov Connection 2023 which will take place at the Lyon Convention Center. Medi'nov Connection is one of the world's leading events in medical innovation and has become a must-attend event for all actors in the field of health technologies. On this occasion, Stéphane Ancel,…

ackomas

For ackomas, the 23 May 2023

Reading time: 1 min.

  • Press Release

Stéphane Ancel new Sales Director at Ackomas

Ackomas, a French company that specialises in publishing SaaS solutions for medical devices, is strengthening its leading position by welcoming Stéphane Ancel as Sales Director. He will be responsible for accelerating growth in the SME, mid-cap and key account segments in the MD industry. This sector is facing growing pressure with the implementation of Regulation…

ackomas

For ackomas, the 01 Apr 2023

Reading time: 2 min.

  • Medical Devices

The European Commission approves the extension of transitional periods for MD

Extension of transitional periods for MD - Further to the implementation of European Regulation (EU) 2017/745 & 746, thousands of medical devices are currently pending certification, a situation which is raising great fears of a widespread shortage in Europe. In particular, the lack of notified bodies, the recent pandemic, and the geopolitical context of the…

ackomas

For ackomas, the 22 Feb 2023

Reading time: 2 min.

  • News

Ackomas will meet you at Techinnov

For the past 17 years, innovation has been the main focus of Techinnov convention. This major event, organized by the Chambers of Commerce and Industry of Paris Ile de France and Essonne, gathers every year more than 600 start-ups, companies and research structures that present their innovative solutions to visitors. Techinnov also includes a rich…

ackomas

For ackomas, the 24 Jan 2023

Reading time: 1 min.

  • Medical Devices

MD, towards an extension of the transitional period?

Since 2017, the regulatory requirements for all medical devices have been strengthened to ensure optimal end-user and patient safety, as well as the proper functioning of the internal market for DMs. Now, conformity assessment of DMs is more complex to ensure the quality and performance of devices. At the start of this year, the European…

ackomas

For ackomas, the 12 Jan 2023

Reading time: 2 min.

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