How we can help with Medical Device Regulation (EU MDR)

How we can help with Medical Device Regulation (EU MDR)

A growing number of medical device companies are adopting ‘touch once’ strategies where they undergo a wholesale redesign of their global labeling processes all in one go.

The drivers for the approach are manifold. Primarily, progressive organizations are cognizant of the ticking clock for EU MDR compliance and the ongoing global climate for regulatory change: they know their current labeling infrastructure is dated and that they need to safeguard against future regulations.

With major providers like Microsoft and Oracle ending their support for several operating systems and databases by 2020/23, these companies have recognized that their labeling solutions could potentially be sitting on unvalidated platforms that expose them to regulatory risk as IT moves to newer platforms.

The importance of selecting a labeling solution that can adapt to a changing world cannot be overstated. We will happily demo our labeling solution and show you how it can help manufacturers to implement EU MDR, as well as to successfully react to future regulations or technical challenges.

Developing 2020 Vision Will Your Labeling Strategy Assure Compliance with EU MDR Developing 2020 Vision: Will Your Labeling Strategy Assure Compliance with EU MDR? Posted in: Achieving Regulatory Compliance, Medical Device, Regulatory & Compliance, Whitepaper -

The European medical device industry is a third of the way into a 3-year transitional period that will culminate with full implementation of EU MDR.

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EU MDR Infographic 10 Sticking points Infographic - Medical Device Label Before and After EU MDR – 10 Sticking Points Medical Device Label Before and After EU MDR – 10 Sticking Points Posted in: Achieving Regulatory Compliance, Business Analysis, Infographic Archives, Medical Device, Operations & Labeling, Project Managers, Regulatory & Compliance -

EU MDR introduces additional information that needs to be included on labels, forcing organizations to design new label templates that make room for data not previously part of the labeling system.

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PRISYM ID 10 Steps to EU MDR Labeling Implementation Guide 10 Steps to EU MDR Labeling Implementation Posted in: Achieving Regulatory Compliance, Medical Device, Operations & Labeling, Project Managers, Regulatory & Compliance, Whitepaper -

Whether you’re producing medical devices within Europe or supplying to Europe, as a manufacturer or supplier, you will need to adhere to the new EU MDR.

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