As a medical device manufacturer, every company must establish a QMS in compliance with 21CFR 820 (if you sell in the US) or ISO 13485 [which is internationally recognized]. With this as a starting point, you might have the Quality...
The process of creating, manufacturing, and marketing a medical device can be extremely difficult to navigate. Once you’ve done the engineering and know your device will work, what are the next steps? How do you take it from a prototype...
Making a change to the design or the manufacturing process of your product that is already out in the field? You have some additional things to consider before making the change. Often times these changes are triggered via the customer...
Clinical Decision Support Software is a tool that is utilized in making decisions for the diagnosis, treatment, prevention, cure or mitigation of diseases and other critical conditions. Such a tool provides clinicians, health care staff or patients with intelligently filtered...
Having a regulatory strategy to bring your device to the market may not seem like the most exciting part of developing a medical device, but it is one of the most important and can result in the most headache if...
A 510(k) is the most utilized regulatory pathway to market a medical device in the US. For a device of the same level of risks, a CE Mark is required to market a medical device in the European Economic area. In...
If you’re considering selling your medical device in Europe, you will need a Notified Body, and you’ll need to understand what role they play in making sure your device is compliant to the EU regulations. A Notified Body is an...
The terms “Form 483” and “warning letter” can incite dread for those that market their medical device in the US, but what exactly are they and how do you deal with them? To begin it’s important to note that an...
Every medical device manufacturer in the US should expect FDA to conduct an inspection at some point, but what exactly does that entail? As a device manufacturer, you know you are expected to maintain a detailed QMS, implement design controls,...
When most people hear the term “medical device”, they think of surgical and hospital tools, like stethoscopes or surgical staplers. With advancing technology and the population’s increasing interest in staying healthy, the field of at-home medical technology is seeing a...