Posts categorized as“Regulatory”

Electromagnetic Compatibility (EMC) testing is a key part of device development for medical or other devices. It consists of two different sets of tests: Emissions testing, and immunity testing. As you might guess from the name, emissions testing looks at the electromagnetic emissions from the device under test (DUT), while immunity testing looks at what […]

“When do I need a Quality Management System (QMS)?” is the most common question that we get asked by new clients who are just entering into the medical device field. The answer depends on your target market and your exit strategy. To be frank, it is somewhat a chicken and egg thing.

What Yeast, Richard Nixon, a CIA agent, a Teenager, Donald Trump and $9 billion dollars have to do with a Fake Medical Device Bad Blood: Secrets and Lies in a Silicon Valley Startup was at the top of my 2018 summer fun reading list.  It was released in May 2018 and written by John Carreyrou (the two […]