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[Whitepaper] Frequently Asked Questions About Medical Devices

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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[Glossary] EU MDR and IVDR: The core terms you should know

[Glossary] EU MDR and IVDR: The core terms you should know

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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SoftGroup is now an official member of GS1 Healthcare

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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[Webinar]: The backup plan for serialization

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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