Elayne Gordonov

FDA 21 CFR Part 11 compliance is mandatory for medical device and pharmaceutical companies that supply products into the United States.

When arteries in the heart become blocked due to coronary artery disease, one of the ways to treat it is through the use of a coronary stent. These are tubular support devices that can be surgically implanted into the coronary arteries to keep them open, allowing the arteries to supply blood to the heart properly.

One of the questions our applications team is most commonly asked is “Why aren’t my systems producing the exact same results?”

Start-up medical device companies face a big challenge when it comes to resource budgeting for innovation and quality.

Medical devices have always been a challenging field in which to develop testing standards.