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...
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...
E.M.M.A. International Consulting Group, Inc. Announces New Advisory Board Farmington Hills, MI, January 16, 2020 –E.M.M.A. International Consulting Group, Inc. (EMMA International), a global leader in FDA compliance consulting for the Biotechnology, Pharmaceuticals, and Medical Device industries, is pleased to announce...
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,...