Regulatory

How does gene therapy fit into the FDA? Is it a medical device, a drug, or a combination product? What if gene therapy can cure a life-threatening disease? There are a lot of questions that can pop into your mind...

Are you looking to expand your consumer base and grow your business? International marketing is beneficial by creating long-term business relationships and increasing brand reputation. Expanding your market to a country like Australia is a smart commercial move, but how...

Whenever there is a public health emergency, such as the Zika virus in 2016 or the current novel coronavirus, there is a rush to get diagnostic tests and other medical products to detect and treat the emergency available quickly. Given...

Augmented and virtual reality first saw its boom in the consumer sector but has recently piqued the interest of the medical device community. Extended reality (or XR, the umbrella term for augmented or virtual reality) can have many uses across...

Laying out a regulatory strategy for your product that visualizes the steps taken to bring a new or modified product to market could be one of the smartest decisions you can take as a start-up company. The regulatory strategy describes...

The transition to the new EU MDR and IVDR tops the list this year with the concerns and confusion it continues to create within the industry. With a limited number of guidance documents to guide the device makers, companies are...

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...