Documentation compliance services for medical devices and regulated industries: compliance checking, terminology consistency, and DHF authoring and archiving.
Based on the official service description
Chinese/English compliance checking in Oxygen, DITA terminology extraction and advanced writing-rule validation; the enterprise edition adds industry rule customisation and private AI model training.
Compliance documentation preparation for FDA / CE, including usability assessment and internal audit requirements.
Clinical evaluation and validation support meeting strict regulatory audit requirements.
Design History File authoring and archiving covering software, cybersecurity, risk management and algorithm documentation.
Assessed per project requirements; contact us for a quote.
Contact us for a quote