by Eric Hanig | Aug 18, 2025 | Uncategorized
We’re excited to announce that our AI-driven compliance platform now includes full support for ICH E6(R3) Good Clinical Practice (GCP) guidelines — for both Investigators and Sponsors. Why this matters:ICH E6(R3) is a cornerstone of clinical trial integrity, ensuring...
by Eric Hanig | Jul 15, 2025 | Uncategorized
Today we announced the addition of General Data Protection Regulation (GDPR) support to its regulatory automation engine, for both UK and the EU. This critical expansion empowers life sciences organizations and their consulting partners to proactively identify and...
by Eric Hanig | Jul 15, 2025 | Uncategorized
Bringing AI-Powered Gap Analysis to Medical Device Security Compliance We’re proud to announce that our platform now provides comprehensive support for the FDA’s Premarket and Postmarket Cybersecurity Guidance—a critical step forward for medical device...
by Eric Hanig | Jul 15, 2025 | Uncategorized
The FDA announced it will expand the use of unannounced inspections at foreign Life Science manufacturing facilities. This marks a clear shift in enforcement strategy — one that introduces even more unpredictability and pressure for global Life Science supply...
by Eric Hanig | Jun 15, 2025 | Uncategorized
Today we announced the addition of Health Canada SOR/98-282 and the agency’s latest Machine Learning-Enabled Medical Device (MLMD) guidance to its regulatory automation engine. This strategic expansion allows medical device manufacturers and consultants to proactively...
by Eric Hanig | May 15, 2025 | Uncategorized
We’re excited to announce that our AI’s continuous gap analysis platform now supports the European Union Medical Device Regulation (EU MDR) QMS requirements — a major milestone that enhances our platform’s ability to help medical device manufacturers navigate...
