Digital Regulatory Runways Complex medical device regulations in a simple flow
Digital Start towards CE-marking
ENTRIES takes you through the questions necessary to determine if your product is regulated as a medical device or an in vitro diagnostic (IVD) device according to the MDR or the IVDR, and if so, what is the risk class of the device. The service then guides you further into other regulatory essentials based on your medical device classification and type.
Finding and interpreting this information would traditionally take anything from hours of flipping through the piles of regulations, to months of not knowing where to look and risking the viable direction of a product development project. ENTRIES puts you on a minute runway and a steep learning curve towards compliance, best practices and a solid foundation for your business.
Complete Report at the End
ENTRIES is regulatory contents turned into a flow. It provides clause by clause references and links to the original requirements throughout the runways. It presents the terminology, examples and guidance from the regulatory sources in an intuitive format and generates a Final Report, with complete references, as a rationale for you to dive into the development of your product.