atrify becomes 1WorldSync
At atrify, we always strive to offer our customers the best possible solutions. Following the acquisition by 1WorldSync, we have been thinking hard about our future strategy and would now like to share some significant news with you. Our goal has been to...
atrify GDSN User Group - March 2023 Position Paper Medical device manufacturers are encouraging EDI solution providers to increase EDI efficiency by using GDSN, the globally used GS1 standard method for exchanging...
EUDAMED is the central information system developed by the European Commission to increase transparency and improve traceability of medical devices in the European Union. As the UDI module is already in production environment...
The introduction of EUDAMED has a significant impact on supply chain management in the medical device industry. However, these positive effects can only be optimized if they are combined with a strategy for exchanging product information with...
I am honored to have been invited as a speaker for the MedTech Europe webinar on EUDAMED, which took place at the end of March. The webinar was organized specifically for the MedTech industry and had over 1,000 registered participants, a...
The European Union introduced the Medical Device Regulation (MDR) to improve patient safety and modernize public health. EUDAMED is a central EU database where information about medical devices is stored and...
We tell you how you can close this gap! In many gap analyses we have conducted, we have found that medical device manufacturers are missing on average about 60% of the data required by EUDAMED. This shows how important it is to...
The EU Medical Device Regulation (EU MDR) covers certain beauty products that were previously not considered medical devices. This means that these products must now meet the same safety and efficacy standards as conventional medical devices.The...
On Dec. 9, the European Commission announced the extension of the validity period of certificates for legacy products on the European market. This has caused uncertainty and perplexity among some medical device manufacturers regarding the...
Lionel Tussau, head of atrify's global healthcare market unit, joined other experts at MedFIT to discuss the topic of "𝐇𝐨𝐰 𝐭𝐨 𝐝𝐞𝐟𝐢𝐧𝐞 𝐲𝐨𝐮𝐫 𝐛𝐮𝐬𝐢𝐧𝐞𝐬𝐬 𝐦𝐨𝐝𝐞𝐥 𝐰𝐡𝐢𝐥𝐞 𝐧𝐚𝐯𝐢𝐠𝐚𝐭𝐢𝐧𝐠 𝐭𝐡𝐞 𝐢𝐧𝐭𝐞𝐫𝐜𝐨𝐧𝐧𝐞𝐜𝐭𝐢𝐨𝐧𝐬 𝐛𝐞𝐭𝐰𝐞𝐞𝐧 𝐯𝐚𝐫𝐢𝐨𝐮𝐬 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐟𝐫𝐚𝐦𝐞𝐰𝐨𝐫𝐤𝐬", Among the key...
The AdvaMed MedTech Conference is the top event for medtech professionals. World-class speakers, an informative program, networking with professionals from the medtech industry and plenty of business opportunities make the Medtech Conference an event that medtech...
Visit atrify at our joint booth TT-14 with USDM Life Sciences at RAPS Convergence, September 11-13, 2022 in Phoenix, Arizona. RAPS Convergence is the world's largest annual gathering of professionals and innovators in the field of...
We are excited to announce our M2M connection and testing with Australia's AusUDID. The Australian Therapeutic Goods Administration (TGA) is preparing for the launch of the UDI database in 2023 and has selected atrify as its M2M test partner....
We are very pleased about the partnership with FactoryPuls. Together we will help medical device manufacturers meet the new MDR requirements. Both companies provide world-class technologies and services to the healthcare industry in the areas of...
With our Healthcare Expert Team atrify will be present this year from September 14-15 at the Healthcare Live! in Hannover! We are looking forward to welcome you at our booth!. Together with our customer Primed Halberstadt Medizintechnik GmbH we will speak on 15.09....
You want to register your medical devices in a national UDI database like EUDAMED or GUDID (FDA) or share them with business partners worldwide, but don't know which solution is best for this? With atrify's Healthcare Navigator you get within...
Visit atrify at booth 529 at the AHRMM22 Conference & Exhibition, August 7-10, 2022 at the Anaheim Convention Center in Anaheim, California.The AHRMM22 Conference & Exhibition is the premier showcase for the latest products, solutions,...
I'm very happy to confirm that for the second year, our representative Lionel Tussau has been reelected Member of the GS1 Healthcare Leadership Team, in charge of leading the strategy of GS1 worldwide for this industry. We thank the community for their vote of...
We'd like to remind you that all medical devices sold in Finland must be registered in EUDAMED (UDI module) - whether new or "legacy devices" - since 2021; and the same will apply to IVD legacy devices by August 2022 already! With atrify, you can easily comply with...
Even if the mandatory registration of medical devices in EUDAMED still seems a long way off until 2023, many experts recommend already dealing with the complex requirements now and start testing and registering in time. GS1 Norway officially recommends using the...
atrify will be participating in GS1 Connect. After a 2-year break, you have the opportunity to meet our experts in person again. EUDAMED requirements are coming fast. We are 1 of only 4 approved vendors for EUDAMED submission. Visit us to learn how we can help you...
Lionel Tussau, the head of atrify Healthcare Market Unit, will participate in the round table organized by the Italian Trade Association Confindustria Dispositivi Medici during the Regulatory Affairs Days on 27th May (digital event), to share the expertise of the...
We are pleased to finally be back at the MedTech Forum and to welcome you to the largest healthcare and medical technology conference. Be there when experts talk about the latest trends and developments in healthcare and technology....
For the last few months, you have been the "happy" project leader for Eudamed! The one who inherited this project that nobody wanted... This topic has already put you in a cold sweat, just trying to get your famous SRN... Now that the UDI module is live (since last...
After years of zoom meetings, it was great to see so many of you in real life. This year's conference was heavily focused on the Scan 4 Safety project, for which atrify provides the GDSN data pool. Healthcare in the UK is starting to move forward beyond COVID, but...
We are pleased to announce that the partnership between GS1 Austria and atrify will be strengthened again. Especially manufacturers of medical devices located in Austria can benefit from the close cooperation between GS1 Austria and atrify. From now on, they have the...
Finally, the live events are back! atrify will have a stand at the GS1 UK Healthcare Conference in London on 17 and 18 March 2022. This year, the focus will be on how GS1 standards are being used to improve patient safety and...
After its consultation on the UDI regulation in the UK, the MHRA is now holding another consultation on the Clinical trial regulation to improve processes and simplify the activity of clinical trial sponsors. Its focus is particularly on "clinical trials and the...
Exchanging data with group purchasing organisations (GPOs) has long been cumbersome and time-consuming for healthcare producers. Each GPO had different requirements and different formats and attributes made the transfer of product data...
Hosting a forum during a pandemic can be quite a challenge, especially when the participants are from the health sector. TÜV Süd, a notified body, has risen to the challenge and made the best of the...
The EUDAMED UDI module for the registration of medical devices has been in operation since 4 October 2021 - voluntary from the point of view of the European regulation, mandatory or almost mandatory according to various European member states. Reminder: 5 years...
The UK regulator MHRA has launched an official Consultation on their future UDI regulation due to close on 26th November 2021. The regulation is expected to enter into force in July 2023. The consultation itself is very thorough, looking at a number of options for...
The Chinese authorities have confirmed that all remaining Class III medical devices must be registered in the CUDID (NMPA UDI database) by 1 June 2022 - 8 months from now. atrify has been associated with the CUDID for years. The...
Following the release of the Actor module, which has been operational since December 2020, the UDI and CERTIFICATE modules went live in EUDAMED on Monday 4 October. This is another important step towards the implementation of EUDAMED and the MDR/IVDR....
As an ongoing effort to provide information on regulations, atrify hosts online sessions in multiple languages on EUDAMED, UDI regulations, and the exchange of product content between trading partners. @GP and atrify are hosting a joint online session "UDI, EUDAMED,...