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From manufacturing to supply chain, food & beverage to aerospace —
explore crucial insights across multiple industries, all here within the Generis Group blog. 

    eBook: Design Thinking with Terumo BCT

    Generis Group is honored to have Palani Palaniappan, EVP, Innovation and Development at Terumo BCT join the speaker...

    Whitepaper: Why Production Forecast Affects Sterilization Method

    A validated sterilization cycle is a requirement for many medical devices, and the appropriate sterilization method...

    What Happens When Life Sciences Messaging Doesn’t Meet FDA Regulations

    Medical device organizations face a number of regulatory and compliance challenges ranging from design and development...

    eBook: How Quality is Your System?

    With the American Medical Device Summit 2016 right around the corner we wanted to take some time to sit down with...

    Whitepaper: Risk Management for Modern Medical Device Makers

    Medical device developers face an array of regulatory, compliance, quality and risk challenges. Throughout the past...

    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...