Simplify complex regulatory submissions

Cutting-edge software solutions for medical device and biopharma professionals

Streamlined Workflows

Standardize templates and reduce manual effort with  AI-augmented authoring.

Collaborative Partnership

Partner to develop software solutions tailored to meet your unique business needs.

Secure and Scalable

Adapt and grow with confidence as your organization evolves.

RegWriter Logo: a pencil with several leafs surrounding it

RegWriterTM AI-augmented authoring platform that improves efficiency, reduces costs, and simplifies your regulatory submission workflow.

SmartComplaintsTM automatically categorizes post-market complaints according to MDCG-recommended IMDRF Annex terminology.