Any start-up that develops a new product in the field of medicine or medical devices has to comply with a lot of rules and regulations. Therefore, they have to set up a quality system: a formalized system that documents processes, procedures and responsibilities. A quality system helps coordinate and direct your organization’s activities to meet regulatory requirements.
In order to obtain both a product license and a market license, your medical start-up will be audited. Once you’ve obtained your licenses, your company will be audited every year. And this involves not only your own organization, but also the companies you work with: from your packaging company, the raw materials, the transport company, the wholesaler all the way up to the hospital that uses your products.
Complying with all these regulations takes a lot of effort and manpower, but it’s all the more important. Without product license you can’t produce and without market license you can’t sell. Getting al the licenses you need is a lengthy process: it can take up to 3 years. That’s why it’s smart for a start-up to start thinking about this right away, so that by the time you reach the clinical phases of a study, you’ll be ready to go.
Do you want to know whether or not your health start-up has to comply with certain regulations or how you can arrange the best quality system? Take a look at our workshops or plan a free consult with one of our experts!
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