12th January 2021 SoftGroup AD, the best in class end-to-end traceability technology provider in the CEE region, today announced that JSC Farmak, one of the largest Pharmaceutical manufacturers in Ukraine, has selected SoftGroup® SaTT solutions to help its modernization to comply with the Тrack and Тrace...
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This video presents the comprehensive single solution for serialization with the proven software capability of SoftGroup and highly reliable machinery provided by PAGO that met the highest customer requirements for its full-stack Track and Trace solution. Let’s talk with facts: More than 13 production line, equipped...
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Currently, the UK is a participant in the European regulatory network for medical devices, but after the end of the transition period, this participation will also end. The Medicines and Healthcare products Regulatory Agency will take on the responsibilities for the UK market undertaken through...
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The EU's Medical Device Regulation (MDR) was officially published on 5 May 2017 and came into force on 25 May 2017. The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).In this whitepaper, you...
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Thanks to the research of the European Pharmaceutical Review, we are witnessing a wide examination of how the pharmaceutical supply chain is faring in the face of growing concerns about the impact of a sudden market disruption on the quality and availability of medicines. A...
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Description The deadline for the introduction of serialization for medical devices and in vitro diagnostic devices is approaching. However, their implementation raises certain questions and challenges for manufacturers, importers, and authorized distributors.We are pleased to invite you to listen to the webcast for the upcoming regulations. Available...
Read More![[Glossary] EU MDR and IVDR: The core terms you should know](https://www.softgroup.eu/wp-content/uploads/2020/10/Untitled-design-38.png)
The European Union (EU) is approaching its deadline to implement the Medical Device Regulation (EU MDR). As the transition period ends on May 26, 2020, a wider and clearer regulatory scope for medical devices is just around the corner. The EU MDR establishes requirements for manufacturers...
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Download the whitepaper now by filling the fields below and learn about the UDI requirements around the world. [contact-form-7 id="8530" title="Contact form - Aggregation Medical devices_UDI requirements"]...
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We are proud to announce that SoftGroup is now an official GS1 Healthcare member! With this membership, SoftGroup and its customers will now participate directly in shaping the future of the healthcare industry for the best outcomes for patients and the healthcare industry in Europe...
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Description The deadline for the introduction of serialization for medical devices and in vitro diagnostic devices is approaching. However, their implementation raises certain questions and challenges for manufacturers, importers, and authorized distributors.We are pleased to invite you to an online training seminar to introduce you to...
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