De Novo

The De Novo pathway provides a route for novel devices, in vitro diagnostics or medical software that lack a legally marketed predicate. It allows manufacturers to demonstrate safety and effectiveness through appropriate clinical and non-clinical evidence while avoiding unnecessary regulatory burden.

Developing a De Novo submission is a complex, multi-stakeholder process. It involves regulatory teams, medical writers, engineers, quality specialists and external reviewers working collaboratively to compile structured evidence, risk analyses and labeling content. Traditional document creation can be slow and error-prone, particularly when multiple departments exchange drafts across disparate systems. Using structured content authoring within a Component Content Management System (CCMS) such as Tridion Docs streamlines this process. Authors and reviewers can collaborate concurrently in a single online environment, track changes transparently and maintain full version control across every component – from device descriptions to clinical summaries. Structured content ensures consistent terminology, traceable updates and audit-ready documentation – significantly accelerating time-to-submission.

At RWS, we help life-sciences organizations modernize their regulatory workflows through structured content and intelligent automation.

Using Tridion Docs, we enable medical device manufacturers to produce and maintain De Novo applications that are compliant, traceable and efficient. Our Human + Technology approach combines regulatory expertise with content automation – giving teams the tools to manage taxonomies, reuse data and collaborate securely online. By embedding structure and governance into every stage of the submission process, RWS empowers organizations to bring innovative devices to market faster – with documentation that’s accurate, compliant and future-ready.