medtech

Increase Productivity? Think Document Control.

Increase Productivity? Think Document Control.

As your company grows, the amount of documents your team creates and manages increase. This is great news and it means that your company is growing! However, that also does not mean productivity must go downhill. Thus, it is important to have a process in place to manage them in a systematic and optimised manner. We call this ‘Document Control’.

Step-By-Step Guide to Classification of General Medical Devices

Step-By-Step Guide to Classification of General Medical Devices

In some countries, product classification principles are standardised across both IVDs and general medical devices but not for some. One good example is the U.S. FDA. 

How about those countries, which have product classification routes designed differently for the two main categories of medical devices such as Singapore?Today, we shall discuss about the classification of a general medical device!

Step by Step Guide to Classification of IVDs

Step by Step Guide to Classification of IVDs

What we are about to share with you is a guide to medical device regulatory classification.

In this guide, we will provide you the step-by-step approach to how your in vitro diagnostic medical device (IVD) will be classified in the United States and Singapore.