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    Guide: Medical Device Commercialization

    In our previous posts we have looked into some of the challenges that documentation can present during a medical...

    An Agile Alternative to Document-Centric Methods for Requirements Management

    The American Medical Device Summit is less than one month away! The summit will draw on the knowledge of over 40...

    Can you turn Regulatory Compliance into an Opportunity?

    Medical device developers are evolving and introducing new products and variants into the market. With this evolution...

    Big Challenges for Testing Today’s Wearable Devices

    Wearable devices have become a commodity; devices act as fitness and health trackers, work and lifestyle guides as well...

    7 Tips for Transitioning to Electronic Medical Device Reporting

    In August 2015 the FDA’s Center for Devices and Radiological Health (CDRH) implemented a requirement for manufacturers...

    Struggling with finding a fully validated Requirements Management Tool?

    Quality control and regulatory compliance are paramount in medical device development. A fully validated tool can help...

    eBook: Medical Device Commercialization Best Practices

    The evolving regulatory landscape and the accelerated pace of medical device innovation are increasing pressure on...

    eBook: A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences

    Medical device manufacturers are operating in a constantly evolving environment. Aging populations, evolving healthcare...

    Surface Preparation for Medical Device Manufacturers

    Surface preparation is a critical manufacturing process that enables sealing, bonding, painting, coating, printing and...