Med Safety Board

Trusted Authority in Advancing Safety Across Healthcare

Products and Services 

  • Drug Labeling & Packaging: Design & Safety Review

    Med Safety Board’s medication labeling & packaging consulting services can help you work through labeling and packaging requirements and safety enhancements for a single label, a group of labels, or an entire portfolio of products, whether for prescription pharmaceuticals, biologics, 503B compounded products, or over-the-counter medications.

    Ideally, labeling and packaging issues should be identified prior to the launch of a new pharmaceutical product to minimize harm and expensive revisions. However, Med Safety Board can help remediate drug safety issues at any point in the life cycle of a product, including post-market implementation.


    More Information » www.medsafetyboard.com/labeling-packaging-design-r...

  • Drug and Medical Device Risk Assessments

    The US Food and Drug Administration (FDA) advises that proactive risk assessments should be utilized by pharmaceutical and medical device organizations to help identify potential use-related errors and to remedy any safety concerns prior to a product
    reaching the market. Med Safety Board experts are able to provide these risk assessments to identify potential errors, as well as strategies for mitigating those risks.


    More Information » www.medsafetyboard.com/msb-risk-assessments

  • Human Factors & Usability Evaluations

    The FDA encourages manufacturers to obtain external clinical safety and human factors expertise to perform proactive risk assessments prior to product launch. Med Safety Board is uniquely qualified to perform these evaluations, which can help you avoid costly delays in go-to market plans, as well as in- market issues that can cause patient harm. Our team consists not only of human factors engineers but also healthcare professionals who work collaboratively to offer real-world, clinical informed validation testing.

    Med Safety Board also offers human factors learning opportunities for industry partners and their teams, such as in-person and virtual collaborative teaching seminars, to help you become more effective in applying human factors engineering principles in-house.


    More Information » www.medsafetyboard.com/human-factors

  • FDA 510(k) Regulatory Support

    Med Safety Board can assist with medication-related device regulatory submissions and responding to regulatory agency requests related to the device labeling, medical device testing requirements and interpretation of the associated testing data, and/or conducting risk assessments to identify any safety concerns with the design of the device, whether pre- or post-submission.

  • Drug Name Review

    Proposed new pharmaceutical brand names need to be evaluated for potential look- and/or sound-alike similarity with other pharmaceutical products in order to help avoid medication errors. Med Safety Board utilizes data from name simulation studies involving practicing healthcare practitioners, knowledge gained from product name issues reported to ISMP, name pair scores generated by the Phonetic and Orthographic Computer Analysis (POCA) system, and comparisons of product characteristics for overlapping or dissimilar attributes to complete its brand name safety testing.

  • Education on Medication and Medication-Related Device Safe Practices

    Med Safety Board can design and present educational programming on medication and medication-related device safety and error prevention to any audience – industry colleagues, your customers, or to healthcare consumers. This may include topics such as how to incorporate safety recommendations into the design of a medication label, causes of medication or medication-related device errors and associated recommended strategies, and medication use systems in various care settings and how your product fits into these workflows.

  • Drug Safety Labeling & Packaging Field Testing

    Understanding how a pharmaceutical or medication-related device product will fit within the healthcare environment in which it is intended is crucial to identifying and mitigating potential risks. Med Safety Board can use our network of healthcare professionals and pharmacists working in the field to evaluate sample products, taking into consideration its setting of use and storage, to identify potential risks.

  • Medication Safety Insights and Qualitative Research

    By bringing together key product users and/or medication safety thought leaders, Med Safety Board can convene focus groups to identify potential safety concerns, gain insights, validate best practice opinions, and brainstorm safety enhancement ideas for new or established pharmaceutical products and medication-related devices.

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