Category Archives: Regulatory & Compliance

Category Archives: Regulatory & Compliance. See our Regulatory & Compliance posts here.

VDC Research: Loftware Expands Solutions Portfolio With Life Sciences-Focused Acquisition

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The need for unique product identification and error-free labeling is greater than ever before, as evidenced by measures taken by leading global regulatory systems, FDA and EMA/EU-MDR. Read More

JUST-IN-TIME LABELING: SHORT-TERM FIX OR LONG-TERM FIXTURE FOR CLINICAL TRIALS?

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Despite Just-In-Time (JIT) production often being the preferred approach in clinical trial supply, it has taken a global pandemic for many organizations to make it a reality. Read More

Webinar Review – Considerations for Global Labeling System

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Find out why continuing with international medical device manufacturing without the support of a true Global Labeling System, will create continual challenges, and why now is the time to take a different approach. Read More

Bringing It All Home: How Label Management Solutions Can Help CDMOS Grow Their In-House Capabilities

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What the challenges are of in-sourcing label management processes for CDMOs, and how they can be overcome by investing in a cloud-based, validation-ready labeling solution. Read More

Efficiently Managing High Volumes of Increased Data for Medical Devices

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Medical device manufacturers face the challenge of efficiently managing increasingly high volumes of data relevant to product labeling in a vast array of different forms. Read More

Why Medical Device Manufacturers Must Look at the Bigger Picture When Implementing a GLS

What are the benefits of a GLS and why are MedTech companies considering it now?

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Clinical Trials: Managing Labeling Approvals with Multi-Language and Multi-Region Regulations

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Now more than ever, the clinical trials’ landscape touches more regions than ever before. As a result, new studies are grappling with the challenge of managing variable local language labeling requirements.  Read More