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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Download the whitepaper now by filling the fields below and learn about the pharmaceutical global compliance requirements around the world. [contact-form-7 id="10410" title="Contact form - Pharmaceutical Global Compliance Requirements Worldwide Overview"]...
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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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The widespread development of technology, together with the effects of the pandemic, has drastically changed the behavior of the pharmaceutical industry. According to a recent survey, we’ve conducted, 67% of pharmaceutical companies had to shift their plans for digital transformation in 2020 due to the COVID...
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EMDN - principles, structure, access EMDN (European Medical Devices Nomenclature) is the official nomenclature, established by the European Commission for use for registration of medical devices by manufacturers in the EUDAMED database. The very first version of it was released on 4th May 2021. In general,...
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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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Benefits of SaaS services in heavily regulated industries like pharma Cloud technology computing is no more a buzzword. It is used mostly for digital services and software. Especially where the IT infrastructure must always be available and accessible. It is not a secret that companies within...
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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 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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Challenges behind the "revolutionary" technology Blockchain has been one of the most-hyped technologies of the last decade. Market research firm International Data Corporation (IDC) forecasts company spending on blockchain to reach nearly $4.3B in 2020 and grow to $14.4B by 2023.1. But as long the blockchain...
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