[Blog] How do legacy devices deal with MDR?

EU MDR`s impact on legacy medical devices     Medical Devices Regulation (MDR) completely changes the legislation and business processes regarding the production and distribution of medical devices. We have already considered the topic of MDR`s changes and requirements, but not the impact on the legacy medical devices. In...

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cloud service provider evaluation

[Blog] Key areas in evaluating a cloud service provider

How to evaluate a cloud service provider?   Cloud services are not already a “tabu” for the pharma industry. In fact, despite the established notion that the pharmaceuticals prefer services and solutions that are on-premises, nowadays they are strongly focused on using new technologies.  The innovative solutions...

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business challenge in front of pharma industry

[Blog] Serialization vs. Pharma industry

The most common challenges in front of the participants of the supply chain     In the end of Q2, we look at the challenges for pharma industry regarding serialization. The serialization requirements are “the new normal” for the supply chain participants. According to the specific market researches,...

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checklist top mdr questions

[Whitepaper] Checklist – Top MDR questions

In 2017 the Medical Devices Regulation (MDR) was published and marked the start of a four-year journey of transition from MDD to AIMDD. From the 26th of May 2021, the MDR will be fully applicable. During the transition, the manufacturers should have informed themselves and...

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eudamed modules

[Blog] EUDAMED – the key role of each module

EUDAMED is a secure web-based portal acting as a central repository for information exchange between national Competent Authorities and the Commission in accordance with the MDR & IVDR Regulations. The intended purpose of EUDAMED is to compile and provide information for the manufacturing, distribution, certification...

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