![[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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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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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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By its definition, the brand promise is a value or experience a company’s customers can expect to receive every single time they interact with that company. But what happens when these promises are quite far from reality? Here are briefly the 5 most common misbeliefs you...
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As of July 1, 2020, the requirements for mandatory serialization (marking and labeling) of medicines, shoes, and tobacco products had to come into force. According to Decree of the Government of the Russian Federation № 955 from 30.06.2020, non-serialized medicines manufactured or imported in Russia from...
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