Quality management system for MedTech startups

As a MedTech startup you will have to think about how to apply to the regulations in the countries of interest. The regulations (IVDR/MDR/FDA) do not require you to be ISO13485 certified, but this standard does cover most of the important aspects relevant for compliance to the European and US regulations.

The first step for MedTech startups is to think about the activities you would like to do within your own organization and what activities you are going to outsource. The main processes to think about are design and development, manufacturing, distribution, sales and service. All of these processes you can do yourself, but it could also be a strategic decision to outsource some or all of these parts to be able to accelerate and reduce risks by using qualified partners for developing or selling your first product.

Once you have decided on the processes you need, you can think about how to setup your Quality Management System (QMS). It is important that your processes follow your way of working. However, many processes are quite standard and could be described by using QMS templates that are made available by different organizations. These organizations can also assist you or take up workload for creating the procedures. It is recommended to have someone internally available within your startup to make sure that the procedures follow your way of working and is owner of the QMS. This person can make sure the procedures are followed correctly by your organization. This person can also make sure that changes are implemented correctly. Change management is an important aspect of the QMS. Your QMS should not be a static collection of archived procedures. As your organization is growing, learning and thereby changing, your QMS will change accordingly.