Resource Library

Bringing a medical device to the U.S. market is rarely simple. Teams face a maze of regulatory pathways, and for new teams working on their first development cycle, the 510(k) submission...

If you work in regulatory affairs, you know how complex submissions have become.One product might require dozens of sequences across multiple regions, each with unique formatting, timing,...

Regulatory deadlines never slow down. Submissions are getting more complex, reviewers expect faster turnaround, and teams are often managing content across spreadsheets, email chains, and...

Every pharmaceutical company lives and dies by its documentation.

The life sciences space used to run on paper-based binders, SharePoint folders, and spreadsheet trackers. And while enterprise software has become the standard for large teams, many smaller...

Regulatory lifecycle management (RLM) transforms compliance from a reactive burden into a strategic advantage. Companies with effective RLM processes scale faster into new markets while...

Medical device companies operate under some of the most stringent regulatory frameworks in life sciences. FDA 21 CFR Part 11, ISO 13485, and EU MDR requirements shape every stage of product...

QMS implementation used to be treated like a background IT project. Get the system in place, hand it off to QA, and move on.

Quality assurance in healthcare should be focused on enabling safe, scalable growth in one of the most highly regulated industries in the world.

Software is no longer just a component of medical devices. Increasingly, it is the device.

Enterprise QMS implementations cost 15x more than advertised, and that's why life sciences organizations are experiencing a dramatic shift in how they approach quality management software. ...