E-Tools for Health Tech
Complex medical device regulations in the simplest formatA Kick-start Towards Market Entry
ENTRIES e-tools guide you through the regulatory principles that need to be understood at the earliest stage of innovation in order to place a medical device, an in vitro diagnostic (IVD) device or any medical device software (MDSW) successfully on the market. The e-tools further help you determine if the innovation is regulated according to the Medical Device Regulations MDR or IVDR, and if so, what is the risk class of the device. Based on the device class and type, as well as your current status of development, ENTRIES generates a personalized draft Regulatory Strategy that further guides you with the next steps towards market entry. To figure out if the AI Act or the EHDS regulation also applies, please find access to more e-tools that guide you through those principles.
Instant Actionable Knowledge
Ask anyone who’s been there and how it was in the first time: Finding and interpreting this information takes anything from days of flipping through the piles of regulations and guidelines to months of not knowing what exactly to do, while risking the viable direction of a product development project. ENTRIES e-tools put you on a minute runway and a steep learning curve towards compliance, best practices and a solid foundation for your business. Join the hundreds of health tech startups and researchers who’ve used ENTRIES to save months of their time in learning the regulatory principles and reaching the market. The steepest learning curve is granted by combining the e-tools with the Regulatory Essentials in Health Tech on-demand training series by our parent company Aurevia and one-on-one coaching or workshops with our regulatory experts.
A Personalized Regulatory Strategy
ENTRIES e-tools are regulatory contents turned into a flow of explanation, education and execution. They provide clause by clause references and links to the original requirements throughout the tools. They presens the terminology, examples and guidance from the regulatory sources in an intuitive format and generate a complete report and the draft Regulatory Strategy to begin your journey to the market. We know your resources are limited. De-risk your entrepreneurship and invest minutes to save months!