Author: Milena Atanasova

[Case study]: A flagship integration by SoftGroup and PAGO

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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Medical devices in UK market after brexit

[Blog] Medical Devices access to UK market after the Brexit

The Medicines and Healthcare products Regulatory Agency will take on the responsibilities for the UK medical device market undertaken through the European system.   Currently, the UK is a participant in the European regulatory network for medical devices, but after the end of the transition period, this...

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mdr questions

[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 with core terms regarding EU MDR and IVDR

[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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