Stay Up-To-Date With Industry Happenings

Our Client Alerts are our way of sharing current regulatory news and insights with our clients and friends of the firm. Our mailing list is huge and many of our Client Alerts are turned into trade press articles upon a media request to do so.

We pride ourselves in not publishing the pablum that everyone else says about a new law, regulation, guidance or regulatory initiative.

We bring to bear our experience, FDA relationships, our constant interface with FDA in meetings, phone calls and email communications to give you "inside baseball" insights into what it all means.

  • Medical Devices With Software Components

    • Authored by: Mark DuVal
    • Published on: November 2, 2018
    Cybersecurity services we offer

    As new applications of technology and data transmission emerge in the medical device industry, so does the ever-present threat of unauthorized access to related datasets and/or the underlying systems.

    With over 20 years of experience working with industry, our in-house medical device software and design consultant, Greg Spar, is well-versed in what it takes to build a secure medical device.

  • Identifiying Cyber Risks in Medical Device Software

    • Authored by: Mark DuVal
    • Published on: October 30, 2018
    Don't be caught unprepared

    Would you risk driving your car without insurance? Maybe you would - if it was for a short drive, or an emergency. But what about doing this for months, or years?

    Almost everyone working in business today has heard about the barrage of threats we have from sources trying to steal, damage, or hold ransom our digital data. Today the focus of attacks has expanded beyond “phishing” attempts on our email or internet accounts. Now even our devices may be turned against us if we do not take steps to protect ourselves and our customers. The numbers of attacks have grown exponentially over the last five years, and there does not seem to be any decrease in sight. All of us know someone who has experienced some form of attack.

    In today’s world, having an inadequately protected medical product (whether it be a hand-held device such as a smart phone application, or a server based medical database) is a lot like driving a car without insurance. If you gamble doing this long enough you will lose!

  • Does your medical device have a software component?

    • Authored by: Mark DuVal
    • Published on: September 26, 2018
    Software or an application can be a part of a medical device

    Many medical products today have a software component. Sometimes software is the single largest component in the design of the product – other times it is a very small part. Sometimes software is not part of the design at all. But does this mean that software can be ignored?

    What if you are creating a product that does not contain software at all, or a product that incorporates another piece of equipment that comes with fully developed and validated software. Is there any need to address software in your regulatory submission for a product such as this? The answer is Yes!

  • Having difficulty understanding the regulatory process for medical marketing authorization?

    • Authored by: Mark DuVal
    • Published on: June 29, 2018

    Are you having difficulty understanding the regulatory process for medical marketing authorization?

    We can assist you through every phase, from strategy development, to responding to FDA, and beyond. Make sure you've covered everything by checking your protocol against some of the areas we help clients with most frequently...

The information on our site is not intended to provide specific legal advice.
Helping clients be appropriately aggressive, yet compliant. TM