1. Understanding the timeline and cost associated with getting ISO 13485 certified.
First, you need to educate yourself regarding the ISO 13485:2016. You can do that by self-education or conducting some course. Then you need to implement the applicable requirements from the ISO 13485:2016 which depends on the type of the medical device. This means that you need to define your processes, prepare all necessary documented procedures, work instructions, and forms. After you have implemented the ISO 13485:2016, then you need to have an audit performed by the certification body. The certification body will check if you have fulfilled all necessary requirements, and at the end issue the certificate.
It is rather hard to estimate how much time you will need for the implementation process because it depends on many things like the number of employees, do you have any experience before with quality management systems, how complicated your processes are, and so on. On average, we can say that for the company with 10 employees it will take 3-4 months, for the company with up to 50 employees, some 8-12 months. But, once again, this is just the estimation.
You have here two parts of the costs. One is the implementation phase and the other is the certification phase. The implementation you can do it by yourself, hiring a consultant or you can buy a documentation toolkit. Documentation toolkit has all necessary documentation required by the standard already prepared so you just need to fulfill the required positions, name of the processes, and similar data.
It is difficult to estimate a consultant’s costs because they are guided by different criteria. For the costs of the certification body, you should ask for an offer, because the prices vary depending on the market and the certification body itself.
You can see how our ISO 13485:2016 Documentation toolkit is composed and what is the cost of it here:
For more information about ISO 13485:2016 please see the following articles:
2. And can we begin selling earlier if we are getting CE Mark via self-certification?
Each medical device before putting on the market must be registered in the local authority. In the case of class I medical devices that require self-education, a local authority is responsible for checking if all documentation properly prepared. Although ISO 13485 is not mandatory, it is up to the local authority to decide whether prior certification to ISO 13485 is required or not.