Risk-Based Approaches at Medical Device and Diagnostic Labeling Conference

    Risk-based approaches to label development and production is at the forefront of labeling team goals, which involves a cross-functional approach to ensure labels and IFUs are compliant and intelligible, regardless of the intended user.

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    As medical device and diagnostic manufacturers continue to develop life-enhancing products globally, product labels and instructions-for-use (IFUs) hold an increasingly important position in providing critical information to healthcare professionals, focused on the safe handling and use of devices. Labeling executives strive to continuously optimize operations, ensuring a streamlined approach to label data collection and regulatory reviews, and face numerous challenges in achieving each step in-line with regulatory requirements. 

    Subject matter experts from AMPLEXOR recently attended the Medical Device and Diagnostic Labeling Conference in Chicago, IL. During this conference, we were able to meet with medical device and labeling industry experts from all over the country, all of whom were interested in risk-based approaches to label development. Conferences such as this one are a good opportunity to learn about trends and upcoming concerns in various industries, and this conference was no exception. “There’s a really good range of people that we want to be talking to” at this conference, says Collette Bowers Vahed of AMPLEXOR. “This show is a very good filtered section of the population, and many of the people that we talk to are actually directly involved in translation.”

    “It’s an intimate show,” says Bowers Vahed. This helps AMPLEXOR speak with various delegates individually about the challenges in each company’s labeling landscape and their stance on risk-based approaches to label development.

    AMPLEXOR Life Sciences works extensively with both medical device and drug manufacturers on a global basis to address the compliance challenges related to risk-based approaches to label development.

    To learn more about AMPLEXOR offerings for translations and packaging and labeling, please click here.

    Published on 21/06/19    Last updated on 28/07/19

    #Language Services, #Regulatory Information Management (RIM), #Life Sciences, #Translation&Localization

    About the author

    Anastasia Crane has worked in Content Marketing for more than five years, and specializes in topics from software as a service (SaaS) to construction and everything in between. She has a degree in English from the University of Colorado and has spent the last 10 years of her career honing her writing and communication skills.

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