In early 2019 Health Canada released more specifics of their Action Plan on Medical Devices. The Action Plan is intended to reinforce Health Canada’s commitment to ensuring that Canadians have access to safe and effective medical devices based upon the most up to date information. It has a three-prong strategy involving: i) improve regulatory rigor […]
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 […]
Looking for a good resolution to improve your medical device commercialization in 2019? Here are 9 great resolutions recommended by our team of engineers, designers, QA/RA, and manufacturing professionals.
“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.
StarFish Medical videos are created to help viewers learn about medical device design, development and manufacture. They are also a great way to get a better sense of the people you will be partnering with at StarFish. The top 10 viewed Starfish Medical videos for 2018 include 2 new videos and many favorites from previous […]
Four new medtech blogs and three new authors joined our 2018 “most read” list. Regulatory was the most popular topic, followed by electrical engineering, software, and supply chain.
We asked our new product introduction (NPI) team to reflect on their collective experiences transferring medical devices from design to production. Their top tips for production readiness are listed below.
On a quiet Monday morning, before the first cup of coffee has been poured, a faint sound can be heard coming from inside the organized chaos of an engineering lab. Tucked away in a corner, somewhere between an ever seemingly broken 3D printing machine and a box of orphaned circuit boards, a laptop screen glows […]
A couple of nights ago I watched The Bleeding Edge on Netflix. It’s a documentary about medical devices, or rather about side effects of medical devices. If you have not seen it yet, I recommend viewing it.
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 […]
Are you developing a device that performs a more effective treatment, incorporates novel technology, or is like nothing else on the market? If the answer is “yes” then the new FDA program for breakthrough medical devices may be your best regulatory option.
Are you a manufacturer of a medical device that is in the early stages of development interested in gathering clinical data in the United States? Your device design will likely change, but the information needed is best gathered through clinical experience as opposed to non-clinical testing.