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Bending Medical Device Regulations?

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At Rev.1 we pride ourselves in getting you to your project goals 2x Faster. Typically, when we meet with clients for the first time, there are dozens of ways to speed up their project plan. Cutting corners by breaking the law is NOT one of them.

With a thorough knowledge of device regulations, we guide clients along the most efficient path through them. Over the years, we have occasionally encountered a client who doesn’t fully understand regulatory requirements and suggests we follow a plan without realizing the legal implications. It might be skipping a material biocompatibility check or falsification of test documents. In extreme cases, we even had a client suggest using prototypes to conduct testing on human patients.

In cases like these, we are firm in informing clients that these activities are illegal. Even setting aside the considerable moral and ethical implications, getting caught skirting the regulations can very easily land you in jail … and even more easily bankrupt you and ruin your career.

In 2016, the FDA issued more than 100 press releases detailing criminal activity, and investigated and pressed charges in hundreds more. As recently as November, medical device maker Biocompatibles pleaded guilty to misbranding and paid more than $36 million in fines. Here is a quote from the FDA: “Sales representatives subsequently told health care providers that the device increased the level of chemotherapy delivered to a liver tumor and resulted in ‘better tumor response rates,’ despite the lack of FDA clearance or approval for that use and despite the absence at that time of statistically significant evidence to support such claims.”

In another case, the FDA Office of Criminal Investigation convicted two company executives who had fraudulently sold surgical sterilizing devices that caused eye damage in 18 patients, one of whom lost sight in one eye. It’s especially disturbing when someone’s criminal behavior results in severe damage or death to patients.

Understanding device regulations is a critical component in medical device development. REV.1 Engineering is deeply committed to keeping abreast of new developments, and ensuring your device’s regulatory requirements will be met.

We all know that moving your business forward aggressively means taking risks, but you don’t want to take risks with regulatory requirements. And you don’t have to be a regulatory expert yourself. At REV.1, we inform our customers of those risks and help them make the best decision for their program.

At REV.1 we’ve got you covered with resources who understand the regulatory requirements for your medical device. You can rest easy, knowing that you will be protected and your project will quickly, and legally, move forward. If you are ready to go 2x Faster, give us a call at 951.696.3933, connect with us on LinkedIn, or send us an email at, and let’s get your start-up funded or acquired.