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Compliance vs Quality assurance

It is difficult to distinguish between quality assurance and compliance. It can also be confusing.
1. Compliance is the act of adhering to certain standards or regulations. When introducing new products to the market, manufacturers must follow the rules established by an authoritative body.

Quality assurance is the process of making sure that an organization meets its quality standards. This involves keeping an eye on the production process to ensure that everything goes according to plan and that the product is of the highest possible quality.

2. One crucial point to keep in mind is that compliance is both mandatory and non-optional, and the organization sets the quality standards to achieve its ultimate objective.

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 distinguish between compliance and quality assurance please watch the complete video.

In this channel, I will slowly upload more videos about compliance, medical devices, ISO 13485, US FDA, 510K, and Medical device registration. So stay tuned with the channel and subscribe to get notifications.