EMC (Electromagnetic compatibility) compliance is an essential requirement for all electronic medical devices. Usually, designers partner with EMC labs (certified testing) facilities in order to assess device compliance. In this blog members of the StarFish Electrical Engineering team share tips for a productive and successful assessment during your EMC lab visit.
Posts categorized as“Regulatory”
An alpha device may look like it’s finished, but it’s not a medical device. A basic principle of medical device commercialization is that even though an alpha device looks like it’s finished – cool housing, looks like a device – it’s not a medical device until it passes regulatory standards and receives regulatory clearance, after […]
Navigating water ingress in medical devices can be tricky, as one of the key requirements for ISO 60601-1 is the protection against ingress. With so much development focused on the functioning of the medical device, ingress protection can be overlooked or left late in the development phase as something that is easily solvable.
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 […]
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.