In every industry it is important to take into account all the necessary standards and make sure that they meet them. This is especially important to the medical industry, because they are playing the peoples lives and health. Hence the reason why the ISO 13485 transition was created.
What is this?
This is ISO is like many of the others, it is about quality management, about how medical services do their jobs, how effective their equipment is. The organizations that produced the medical devices are taken into consideration. This certification will prove that they complied to the standards of the quality management in the medical industry.
The benefits of it?
The ISO 13485 transition can be beneficial on various accounts. One of the main benefits is that your costs will be reduced, and with efficiency rising you are able to gain more productivity. This is because it proves that they were following the correct procedures and not cutting corners which could lead to mistakes if done so. Also it will meet the customer requirements as they have everything they asked for, and the equipment plays a huge part in this. Moreover it will define the key responsibilities and roles of the employees to a better extent. And finally they will be fulfilling regulatory requirements.
Who can do this?
If you want to get this certificate you can contact CCIS and they will provide you with auditors. This way you can check if you meet the standards, as you must do in order to continue the business.