Keep track with our design history file software

Working with the right design history file software can make all the difference to the development an ultimate compliance of your medical device. Your design history file (or DHF) is a detailed and organised documentation which includes the stages and processes of product design and development, through to the completed medical device.

Creating a DHF is an essential part of medical device compliance regulations and finding the right software to collate your data for the DHR is critical to the success of your product development. Tento+ empowers businesses to achieve regulatory compliance with ease, saving you time and reducing complexity.


What is a design history file?

A design history file (often referred to as a DHF) is the details documentation which tracks the processes and procedures of a product’s design and development through to the point that it is a completed device. Creating an accurate and complete DHF is a mandatory element of medical device compliance regulations and the step by step activity relating to your design history file will be at the heart of the journey through your product’s evolution.

Created by engineers for engineers, Tento+ is a simple and highly effective tool that allows you and your team to collaboratively input into a clear, organised and detailed design history file.

Assure Compliance success with Tento+

If you are looking to meet regulatory standards for your medical device, Tento+ is the new way to take the complication out of your journey to compliance.

Simply check the appropriate keywords relevant to your device and Tento+ will instantly create an individualised checklist for your product’s regulatory requirements. Tento+ will then allow you and your team to manage activities, record testing results and track progress. To try our free Tento+ demo, simply complete the form.