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    Whitepaper: Medical Device Leaders’ Comprehensive Guide to Human Factors Engineering

    Developing a medical device is already a long, involved, and often expensive process. Adding time and personnel to conduct human factors engineering (HFE) seems like a high cost addition, and for what benefit? When you take the time to fully and consistently integrate HFE into your medical device development process, you’ll make a better, safer, more intuitive product. And that will better serve not only your users but your sales goals.

    Whitepaper: How to Better Source User & Safety Needs for Your Device’s Traceability Matrix

    Creating a comprehensive traceability matrix hinges on sourcing accurate user, safety, science, and technology needs related to your medical device. Like most companies, your firm is probably science-and/or technology-driven. You’re comfortable documenting these needs in your matrix. But user and safety needs? You have a harder time figuring out where to look for those.

    Whitepaper: The Ultimate Playbook for Launching a Medical Device Startup and Bringing Your Product to Market

    If you’re reading this, you probably have a viable idea for a new medical device — and that’s exciting. You’re ready to launch a startup and get your product into the hands of the users who need it most. But beware. Bringing a medical device to market is a years-long process full of complex regulatory hurdles and business decisions — considerations most product inventors (doctors and scientists, namely) aren’t accustomed to making. Add to that the desire to found a sustainable startup and you’re really facing an uphill battle. The good news? There are some prescribed steps you can take — that many startups often overlook — to ensure you’re on the right track.

    Whitepaper: How to Leverage Your Medical Device Use Specification to Build a Better Product

    Medical device development is full of regulatory hoops and documentation. Unfortunately, it’s all too easy to view some of the requirements as little more than “paperwork.” The use specification document is a prime example. Composed of just a handful of short questions, the use specification document asks for basic details about your medical device: what it is intended to treat, how it functions, who will use it, and in what environment.

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