MedTech: Does Your ERP Cover Everything?

USPs of MDM system in comparison with ERP for Medical Technology companies

ERP systems offer medical device manufacturers many options for controlling their processes and planning resources. However, they do not cover some use cases such as master data management, as is required in the industry to comply with the MDR. ERP (Enterprise Resource Planning) systems offer numerous possibilities for companies to keep track of figures, data, […]

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MDR/IVDR: Which supportive initiatives are available?

Do you need help understanding MDR/IVDR

New regulations, such as the MDR and IVDR, not only provide the industry with opportunities like reorganizing and imroving processes.  The industry is confronted with several hurdles as well. Companies do not have to solve these on their own. Especially online, there is now a multitude of easily accessible and free resources that support companies […]

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New Whitepaper: 7 Steps to UDI Compliance

Whitepaper: UDI Compliance MDR IVDR

In the context of the MDR, UDIs are an essential topic. After all, they not only have to be applied to the product and label itself, but also serve as a key for the EUDAMED and are part of the documentation. We have summarised all information on the different UDI types for you and defined […]

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Counterfeiting? Medical Product Alerts in the securPharm System

Alerts in securPharm, NMVS, EMVO

Alerts in securPharm and EMVS Approximately two years after the EU-wide Falsified Medicines Directive (FMD) came into force, many false-positive alerts make it difficult to find actual falsifications. Both, the national systems (NMVS) and the EMVS are working on reducing these alerts. Although the number of false alerts in the European anti-counterfeiting systems has decreased […]

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Global Compliance: Russia | Success Story

Success Story: Dolorgiet/Dr. Theiss Naturwaren are working with tracekey for Russia Serialization

Pinpoint Landing with Ibuprofen Manufacturer Dolorgiet Product: mytrackey PHARMA The Challenge Russia has become an important export country for Dr. Theiss Naturwaren GmbH in recent years. The company Dolorgiet, which is part of the Dr. Theiss Group since 2016, has been selling its product range not only in Germany but also in Russia since 2008. […]

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Customer Satisfaction 2020 at tracekey

Kundenzufriedenheit/customer satisfaction

Through daily contact with our customers, we know in most cases which topics are currently important, whether certain features have priority or how satisfied our customers are with us overall. Nevertheless, it is important to ask further questions regularly. We did so in the 2020 retrospective, and give a brief overview here for our customer […]

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The Brexit Impact on Pharma + MedTech Industry

What impact has the Brexit on the Pharma and MedTech Industry?

It has taken four years for the British to finally leave after their referendum against remaining in the European Union. Despite the last-minute trade deal, the impact of the Brexit on the Pharma and Medtech industries is huge, and they are left with only a little concrete information.  In 2016, just over half of the […]

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2020: Year in Review

Jahresrückblick/Review 2020

When the first lockdown started in Germany in March, we did not yet know how the global pandemic would affect the pharmaceutical industry and thus us. We are happy to say that 2020 was a good year for us from a professional perspective. Particularly, we have to thank our employees for this, who gave their […]

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Virtual UDI Practice Day: Meet us

GS1 Solution Partner tracekey, UDI Praxistag MDR

As in 2019, this year a two-day GS1 conference about the topic UDI will be held. (Unique Device Identification, part of the Medical Device Regulation) When? 7.-8. December What to expect this year Unique Device Identification is based on three pillars, which will again be the focus of this year’s GS1 UDI Practice Day. The […]

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How digitalization contributes to more quality

Digitizing Quality Management

| Our student trainees Software development and cloud computing require continuous development to steadily improve current operating principles. A significant job in this regard is done by our student trainees, who intensively work on projects that show us new technologies and approaches. Lynne has been working for tracekey as a student trainee since the end of […]

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