• 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.

  • News

Happy Season Holiday

As the year 2022 will soon come to an end, the entire Ackomas team would like to thank you for your trust and for this year rich in new collaborations. We wish you a wonderful holiday season and for the year ahead, many successes, creativity, dynamism, without forgetting joy and prosperity. We wish you all…

ackomas

For ackomas, the 24 Dec 2022

Reading time: 1 min.

  • Medical Devices

MD compliance and certification, the key role of QMS

Manufacturers are held directly responsible to competent authorities for their medical devices. Regardless of the device’s class, a Quality Management System is mandatory for proving product quality control. While ISO 13485 is not directly required in order to obtain the CE mark,[1] it remains a recognised reference that demonstrates the manufacturer’s compliance with the laws and…

ackomas

For ackomas, the 13 Dec 2022

Reading time: 3 min.

  • Medical Devices

UDI for MDs – identifying the right manufacturer to ensure regulatory compliance

Thousands of companies operate in the field of medical devices (MDs) throughout Europe, and all of them are affected by the implementation of Regulation (EU) 2017/745. This new regulation has considerably increased the level of requirements for MDs, bringing them in line with those of the pharmaceutical industry. It also introduces improved procedures for clinical…

ackomas

For ackomas, the 11 Nov 2022

Reading time: 5 min.

  • Press Release

Roger F. Sherwood “Article of the Year” Award Winners Unveiled

As it has done every year for nearly 30 years, ISPE's magazine, Pharmaceutical Engineering®, has just announced the winner of the Roger F. Sherwood Award, which recognizes the best article of the year for quality and excellence in content for the pharmaceutical industry. For this new edition, no less than 35 articles were submitted to…

ackomas

For ackomas, the 13 Oct 2022

Reading time: 2 min.

  • Wine & Spirit

Wine labels, learn to decode them

Between the mandatory and optional information, there are also free indications. If those informations are useful for the consumer to better identify the quality of a wine, they are also very important for the manufacturer. It is indeed required to be in compliance with European standards that impose strict regulations on labeling in terms of…

ackomas

For ackomas, the 10 Oct 2022

Reading time: 4 min.

  • Press Release

Traceability and Medical Devices, the expertise of Ackomas and @GP

At a time when international regulations are multiplying, traceability is at the heart of all concerns. This is a major topic that will be addressed during the next edition of the International Medical Device Days. This annual event, which brings together professionals involved in the life cycle of medical devices, is organized by Euro-Pharmat, one…

ackomas

For ackomas, the 05 Oct 2022

Reading time: 2 min.

  • News

Meet Ackomas at Euro-Pharmat

Come meet Ackomas and @GP аt Euro Pharmat [1] – the 32nd National Medical Device Training Days will be held at Espace Encan in La Rochelle, from 4-6 October 2022. Ackomas will be able to answer аll of your questions about traceability, unit identification, Eudamed registration, as well as the current regulation and how we…

ackomas

For ackomas, the 05 Oct 2022

Reading time: 1 min.

  • Press Release

Ackomas unveils its new website

Ackomas, a recognised specialist in unit identification and data analysis applied to medical devices, the pharmaceutical industry and the wine and spirits industry, has revealed its new, fully updated website.  A highly modern, functional website The intuitive homepage is divided into separate information sections. The institutional information in the first section lets you get to…

ackomas

For ackomas, the 05 Oct 2022

Reading time: 2 min.

  • Medical Devices

The European Medical Device Nomenclature

The European Medical Device Nomenclature is an essential document for all MD manufacturers who wish to place their products on the market. The first, essential step is to define the class assigned to the product. This is indeed of great importance. This step will define the regulatory requirements which will need to be met to…

ackomas

For ackomas, the 05 Oct 2022

Reading time: 2 min.

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