Always Stay Ahead -
Today and Tomorrow

SaaS in Life Sciences is different. It's not about pushing out features quickly or uptime stats. Here, everything revolves around regulatory expectations, patient safety, and being ready for inspection...

As the EUDAMED compliance deadline draws near, regulatory affairs teams across the medical device sector are under growing pressure to ensure their organizations are ready. With significant...

EUDAMED is one of the most comprehensive regulatory systems globally. For each device, manufacturers must manage 208 data elements and comply with 300–400 validation rules to ensure...

EUDAMED is recognized as one of the most detailed regulatory systems worldwide, and its approach to the parent-child UDI-DI hierarchy adds significant complexity. Manufacturers must accurately...

With regulatory requirements continually evolving, managing Unique Device Identification (UDI) data across different international markets has become
increasingly challenging. Each regulatory...