Author: Emma International

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...

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...

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...

Do you have a low to moderate risk medical device that does not have a substantially equivalent predicate device? Are you trying to figure out how to navigate the regulatory pathway for marketing your device? Prior to 1997, with the...

ISO 14155 [Clinical investigation of medical devices for human subjects – Good clinical practice], as the name suggests, addresses good clinical practices for all pre- and post-market clinical investigations that determine the safety and performance of medical devices. The final...