Medical Device


The importance of medical device labeling has increased significantly since PRISYM ID developed its first URS for a validatable enterprise labeling solution with a major global medical device manufacturer (and long-standing client) in 1999.

However many within the industry still remain unsure of regional regulations around the quality requirements for medical device label inspection, such as the FDA’s UDI, the EU’s MDR and FDA 21 CFR part 11.

A broader view of the labeling procedures is essential. In the battle to deliver safe, accurate and compliant product information, it’s not just about the quality of the medical device label – it’s also about the data. By implementing a lifecycle medical device label software supported with up to date validation documentation based on the GAMP 5 Model, you can ensure peace of mind.

The size of the organization does not matter — the FDA and other regulatory bodies do not draw distinctions - so SME organizations also have to take a strategic approach to the management of their data and that is where we can help with our scalable and validatable medical device labeling software solutions.

Through our NEW Lifetime Partnership Program we offer lifelong support on a flexible basis; working together to achieve the vision, objectives and requirements that underpin your labeling strategy as you grow.

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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This solution provides organizations with complete label integrity to meet the strictest compliance requirements for FDA & EU regulations, specifically FDA 21 CFR Parts 11, 810, and 820.

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This solution enables organizations to address the challenges of complying with FDA and other regulations by delivering access to a compliance ready platform in the Cloud.

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Our team of in-house compliance and validation subject matter experts and professional services and support teams can support you from implementation through beyond delivery.

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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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