“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.
Posts categorized as“Quality”
In a previous medical device company, I worked on a project where First-to-Market (FTM) was a deemed a priority for the company’s survival. To meet that highly compressed timeline, we decided to skip the phase-gate process and replace it with a FTM production release strategy. FTM product commercialization carries a much higher overall project risk […]
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.
When I arrived at StarFish with my idea for a patient handling device, I had just completed my engineering degree and was searching for further education in medical device development. Fortunately for me, StarFish provided master-level classes (albeit unaccredited) in project management, including Dealing with Vendors 101: Expect Delays and QMS 201: How to Maintain […]
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.
Bringing medical devices to market in a single country can be a regulatory challenge. The process often becomes much more complex when marketing in multiple countries and navigating medical device international regulations. A comprehensive understanding of current regulations in each country of interest is required as device laws and regulations are constantly changing. If you’re […]
ISO/IEC 17025:2017 includes many changes. There are three main points to keep in mind: more options, involvement of risk, updates in current technology.
If I was to describe design control for consumer vs medical design in sports terms, medical design would be cricket and consumer design would be ice hockey. That is to say medical devices use a slow, carefully considered and accountable design methodology while consumer goods are bunch of aggressive speedsters shooting the puck around hoping […]
There are lots of stories about FDA recalls where the FDA notes that if the vendor had followed the FDA’s approach, the recall could have been avoided. With that as our inspiration, our blogging team of medical device designers, developers, QA/RA, and manufacturing professionals recently brainstormed 11 medical device development mistakes that have surfaced multiple […]
The New Year brings reflection and desire to improve. We asked our designers, engineers, manufacturing, supply chain and regulatory experts to consider projects finished in 2017 and think about things they could have done better or wish they had considered. Here is their list of 2018 resolutions and smart things to do that would speed […]
Bringing a product to market is a challenge, add in the regulatory complications of a medical device and the task can appear overwhelming. But, is it?