Ger O'Carroll

FDA Medical Device Classifications Explained

by Ger O'Carroll
To sell a medical device product in the US, you need approval from the FDA (the Food and Drug Administration). A key part of getting FDA approval is the classification of your medical device. Not only will the classification determine much of the design and development process, it will also determine what is required to get approval. This is because the process for getting FDA approval differs depending on the classification of your medical device. This is very similar to the system in the EU. We covered the EU medical device classification system in a previous blog. In this one,...

EU Medical Device Classifications Explained

by Ger O'Carroll
Not all medical devices are the same. Some are non-sterile and pose minimal risk to patients, while others are implanted in the body and carry a high risk. Therefore, regulations for medical devices must distinguish between the different types, setting appropriate requirements for regulatory approval depending on risk. Regulators do this with a classification system. In other words, understanding the classification that your new medical device falls under is a crucial step in the design and development process. The classification will inform how the development progresses as well as the steps required to obtain regulatory approval. EU vs US Regulations...

Quality Systems and Design Controls in the New Medical Device Development Process

by Ger O'Carroll
Design controls are essential to ensuring your medical device idea achieves regulatory approval. Without design controls, you won’t be able to launch your product, while the poor implementation of design controls, particularly in the early stages of a project, will delay the launch of your product. What are design controls? Design controls are part of the Quality System that you must have in place before regulators will allow your product to enter the market. So, let’s start there. An Introduction to Quality Systems All new medical device products need a Quality System to comply with regulations. In the US, this...