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’.
The pathway from design to commercialisation for a new medical device can be complex and full of uncertainty. A specific product claim or intended use can lead to varying product classification and registration path due to differences in laws and regulations of different markets. A regulatory strategy will help you to bring into consideration the various regulatory issues and put together a plan that will bring your medical devices into the target markets.