A medical device is intended for use in the diagnosis of disease or other conditions, or the cure, mitigation, treatment or prevention of disease in man or animal. They do not achieve their primary intended purpose through chemical action. Examples of medical devices range from low-risk things such as syringes or surgical gloves, to more complex x-ray machines or pacemakers.
Medical devices fall into three categories: Class I (low-risk), Class II (medium-risk) and Class III (high-risk.) Depending on the classification of the device, the submission type required differs.
At Deenamic, we provide compliance support to assist manufacturers in meeting the requirements, understanding the nuances and novelties of the latest regulatory revision and complete the submission to all relevant regulatory bodies.