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…
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
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…
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 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,…
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…
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 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…
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…
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…
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…
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…
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…
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…
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…
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 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…
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…
The authors
