Reviewing medical device technical files to uncover compliance gaps, strengthen supporting evidence and remediate documentation for regulatory and Notified Body review.
Technical documentation can develop gaps as devices, evidence and regulatory requirements evolve. DnA examines the complete documentation set to identify weak links, inconsistencies and missing evidence, then defines focused remediation actions to bring related records back into alignment.
Preparing technical files for Notified Body or regulatory review
Resolving deficiencies identified during previous assessments
Updating legacy, incomplete or inconsistent documentation
Strengthening traceability between regulatory requirements and supporting evidence
Assess technical file completeness, identify documentation deficiencies and review Clinical Evaluation Reports for gaps, inconsistencies and required remediation.
Review GSPR traceability, risk management documentation and PMS/PMCF records to improve consistency across connected regulatory evidence.
Review verification and validation evidence, IFU and labelling documentation, while supporting structured responses to Notified Body findings and queries.
Effective remediation is not simply about correcting individual documents. DnA Regulatory Solutions examines how evidence flows across the technical file, helping teams resolve discrepancies and strengthen the connections between clinical, risk, post-market, validation and product information.
Review CER, GSPR, risk management and PMS/PMCF documentation for alignment
Assess V&V evidence alongside IFU, labelling and applicable device information
Organise remediation actions and supporting evidence for Notified Body responses
From Identified Gaps to Defensible Evidence:
A technical file should present a consistent regulatory story. DnA helps identify where that story breaks down, prioritise remediation and reconnect supporting evidence so documentation is clearer, traceable and better prepared for regulatory scrutiny.
The review can cover overall technical file completeness, CER, GSPR traceability, risk management, PMS/PMCF, verification and validation evidence, IFU, labelling and other supporting documentation relevant to the identified gaps.
Yes. Existing documentation can be assessed first to determine what remains suitable, what needs updating and where missing or inconsistent evidence requires targeted remediation.
Yes. DnA can help review identified deficiencies, organise the required remediation evidence and prepare structured documentation to support responses to Notified Body queries or findings.
Identify documentation gaps, resolve inconsistencies and bring clinical, risk, post-market, validation and labelling evidence into better alignment.