Requirements Archives

Unique Device Identifiers

‌ As with most highly regulated industries, the medical device industry requires high quality and safety...

‌ Project Management, as it is classically defined, can be described as “…the use of specific knowledge, skills,...

‌ A lot of work goes into a 510k submission for a medical device. Companies that submit a 510k for a product...

‌ CBD has been growing more and more popular in the US, both in medical products and in products for everyday...

‌ Cervical Cancer is the fourth most common cancer in the world in women[1]. Nearly all cases of cervical cancer...

‌ For a medical device that comes into contact with a person’s skin, biocompatibility testing is required by the...

‌ The design and development process is long and challenging. At the end of the process comes what is known as...

‌ Cervical cancer is something that every woman has to be concerned about. More common in women over the age of...

‌ One of the main reasons the Federal Food and Drug Administration issued warning letters to CBD companies or...

‌ As 2021 has come to a close and companies are holding and finalizing their last management reviews, quality...

‌ Labeling for medical devices is under strict regulations. The requirements are dependent on the class of...

‌ Developing a Design and Development Plan is a part of the design controls process required by the FDA for...