27/01/2023
Compliance in the medical device industry is an important thing to understand. Many questions will come when you will think about the compliance of your device or support that you are trying to sell.
So, why do we need compliance and why is it important?
- Manufacturers of medical devices must comply with all applicable laws, regulations, and standards for their intended markets.
- Main regulations and standards are ISO, EU MDR, US FDA, 510K etc.
- These regulations and standards ensure that Manufacturers develop safe and effective medical device that meets customers' need.
- Be noted that regulatory compliance is compulsory
- It must be followed by any business wishing to produce healthcare devices or medical devices or services.
To demonstrate compliance, we can say that manufacturers must meet the requirements established by the regulatory bodies.
I know you have many questions. Please watch the video it will answer many questions. If still you have some questions that are not answered in this video I will gladly help.
https://lnkd.in/eBnQFGfg
https://youtu.be/u7dvmroxXnc
Compliance in the medical device industry is an important thing to understand. Many questions will come when you will think about the compliance of your devi...