Technical Documentation Review and Gap Analysis
Practical RA provides structured reviews of existing regulatory documentation to identify gaps, risks, and remediation priorities.
Why Technical Documentation Review Matters
Many manufacturers accumulate regulatory documentation over time without periodic holistic review. Changes in regulatory requirements, device design, or intended use can introduce inconsistencies that are not immediately apparent. Technical documentation reviews provide an opportunity to identify and address these issues before formal regulatory assessment or audit.
Under EU MDR, IVDR, and FDA requirements, documentation must be internally consistent and aligned with current regulatory expectations. A technical documentation review assesses not only whether required documents exist, but whether they are coherent, traceable, and defensible. Common findings include misalignment between risk management and clinical evidence, outdated labelling claims, or PMS plans that do not reflect current device use.
Documentation reviews are particularly valuable prior to Notified Body assessment, FDA submission, or changes to regulatory scope. Early identification of gaps enables targeted remediation and reduces the likelihood of regulatory findings or review delays.
How Practical RA Can Support
Practical RA provides documentation review services including:
- Review of technical documentation against applicable regulations
- Identification of gaps and inconsistencies
- Traceability assessment across documentation sets
- Prioritised remediation recommendations
- Support for documentation updates and alignment
Our focus is on producing documentation that is clear, consistent, and defensible from a regulatory review perspective.
