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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In fact, this is jargon from the highly technical field of supply chain management. But what actually is included in the L1-L5 serialization solutions? Here is the simplest explanation with less jargon. Moreover, what makes SoftGroup the best choice for all your track and trace...
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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Since the European medical device regulation is experiencing a major overhaul medical device manufacturers have to adjust their strategic approach to go through this change smoothly. The EU regulators take this action an effective step towards enabling the Digitalization of the Industry. Successful regulation compliance is...
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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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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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Learn how to protect your production efficiency Many players in the pharmaceutical industry have been feeling the pain of serialization solutions that are not their “cup of tea”. SoftGroup often hears from your peers about these struggles: overpromised and underdelivered capabilities, high rates of unexpected issues and...
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Pharmaceutical companies will achieve meaningful cost-savings by using traceability and aggregation solutions. A large part of these changes come from an upgrade in the production process. Nowadays, many pharmaceuticals see this full solution as a key advantage. Download the whitepaper now by filling the fields below...
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Besides the weather conditions in the summer, the last months in Russia is getting hotter for the pharmaceutical industry. This is a fact as a result of the forthcoming regulation for mandatory marking and labeling of all medicines. Considered for the most complex regulation all over...
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