Entries for Health Tech

Complex medical device regulations in the simplest format

A Kick-start Towards Market Entry

ENTRIES guides 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 software successfully on the market. The tool further helps you determine if the innovation is regulated according to the MDR or the 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 of a Regulatory Strategy that further guides you with the next steps towards the market entry.

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 puts 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.

A Personalized Regulatory Strategy

ENTRIES is regulatory contents turned into a flow of explanation, education and execution. It provides clause by clause references and links to the original requirements throughout the tool. It presents the terminology, examples and guidance from the regulatory sources in an intuitive format and generates 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 – invest minutes to save months!

Find more details on the available Entries tools from here. Contact us for complete access!(Note: The old EU directives tool is made obsolete in 2024.)

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