Medical Devices

MEDICAL DEVICE LABELING

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 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 label – it’s also about the data. By implementing a lifecycle label management solution 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 labeling solutions.

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OFFERING THESE PRODUCTS AND SERVICES...

PRISYM 360

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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PRISYM SaaS

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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SERVICES

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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MEDICAL DEVICE LABELING RESOURCES

EU MDR infographic - EU MDR – Is the Industry Planning for It? Are You? EU MDR – Is the Industry Planning for It? Are You? Posted in: Achieving Regulatory Compliance, Business Analysis, Infographic, Information Technology, Medical Device, Operations & Labeling, Project Managers, Regulatory & Compliance, Supply Chain -

Whether you’re producing medical devices within Europe or supplying to Europe from the rest of the world, as a manufacturer or supplier, you will need to adhere to the EU MDR by May 2020.

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