The consideration of certification and regulatory issues is an important step for bringing out a new product to the market in the field of healthcare. Many startups feel overburdened or intimidated by the regulatory issues, which can be often become a major obstacle for realizing a new product.
There are very expensive, not self-explaining products for the CE conformity declaration. A consultant is often very expensive and not really capable of dealing with content related issues.
How could the process of preparing a CE conformity declaration be made easier or be supported especially for a layman?
Experts in certification and regulatory processes, maybe software developers.