Medical Innovation Exchange

Labeling

IQ OQ PQ and Its Role in Labeling System Validation

IQ OQ PQ and Its Role in Labeling System Validation     In highly regulated industries including medical device manufacturing, pharmaceuticals, and life sciences, regulatory authorities such as the FDA and the European Union (EU) have guidelines related to process validation to confirm a company’s processes will result in reliable outputs and meet all necessary quality …

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From TikTok Trends To Counterfeit Drugs: How Better Labeling Systems Can Help

From TikTok Trends To Counterfeit Drugs: How Better Labeling Systems Can Help      Dupes of goods like make-up, homewares or groceries are fueling viral social media trends as money-savvy consumers clamor to get their hands on them. The term ‘dupe’ might have made its way into the lexicon as a way to describe anything from …

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EU MDR: Ensuring Labeling Compliance

EU MDR: Ensuring Labeling Compliance      In July 2023, the European Parliament granted an extension to the new European Union Medical Device Regulation (EU MDR). This extension acknowledges the challenges that have arisen due to slow market readiness and lack of notified bodies, and  grants companies additional flexibility to meet the demand for safe, innovative …

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How Real-World Evidence Helps Medical Device Manufacturers Drive Value

How Real-World Evidence Helps Medical Device Manufacturers Drive Value     Real-world evidence (RWE) captured during the testing phase for medical devices and during the post-approval period helps key stakeholders understand the clinical outcomes that can be achieved by using a particular device—including by population. RWE also offers important opportunities to ensure medical devices are used …

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