Complaint handling can be a daunting task especially if you are a small company. 21CFR 820 requires customer complaints to be handled by a designated customer handling unit and if you are a small company this might seem a little...
Do you have a medical device that treats or diagnoses a life-threatening disease? If yes, your device may be eligible for an expedited review pathway called the Breakthrough Devices Program. The FDA defines a breakthrough device as any device (or...
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...