Start-ups and companies that want to enter the medical technology sector easily underestimate the effort required by standards and laws. Therefore, it is important to deal with the standards and regulations already during the planning phase in order to avoid unexpected hurdles later on. Anyone who has ever read standards and laws knows that they are not easy to understand and leave a lot of room for interpretation. This is where we can provide support and "translate" the requirements in order to be able to implement them in the real world. The MDR requires medical device manufacturers in all cases to demonstrate an effective quality management system as a prerequisite for the authorisation and placing a product on the market in the EU. This includes above all the introduction of an effective risk management system. Medical device manufacturers must define the processes within the company and document them in procedural instructions. In a so-called "QM manual", quality policy, role descriptions, activities and their interrelationships are regulated.
Quality management should primarily serve as a guide for the company and its employees in their daily work. Unclear or non-existent procedural instructions reduce efficiency because employees have to think about the procedures over and over again, or because the work is repeatedly done in different ways. It is very easy to regulate either too little or too much. Both can disrupt daily work immensely.