Ensuring Your Documentation Meets Compliance Requirements
For many regulated products — especially those requiring CE Marking — a Technical File or Design Dossier is a mandatory legal document demonstrating conformity with applicable standards and directives.
BQCIS experts meticulously review these files to verify the presence and correctness of all essential components, such as design drawings, test reports, risk analyses, user manuals, and conformity declarations. Each section is assessed for completeness, proper reference to harmonized standards, and alignment with the relevant regulatory framework (e.g., MDR, LVD, EMC, or Machinery Directive).
This proactive review prevents costly certification delays and ensures your submission to authorities or Notified Bodies is fully compliant, defensible, and audit-ready.
Key Documentation Review Activities
Completeness & Standards Check
Reviewing all documentation elements (risk analysis, test reports, drawings, user instructions) and verifying that harmonized standards were correctly applied.
Test Report & Evidence Verification
Cross-checking all testing evidence to confirm that results adequately demonstrate product compliance with applicable directives and standards.
Key Benefits of a Documentation Review
Mitigate Compliance Risk
Detect missing elements or errors before submission — reducing the risk of certification rejection or regulatory penalties.
Accelerate Certification
A complete and properly structured Technical File minimizes follow-up queries and speeds up approval timelines with Notified Bodies.
Ensure Audit Readiness
Maintain fully traceable and compliant documentation that can be easily presented during audits or market surveillance inspections.
Demonstrate Due Diligence
Proves a proactive commitment to product safety and legal compliance — strengthening brand credibility and trust.
Success Story
Technical File Review Prevents Certification Delay for Medical Device
A medical device company preparing for MDR certification faced uncertainty about the completeness of its Technical File.
BQCIS performed a comprehensive document review, verifying compliance with ISO 13485 and ISO 14971 standards, ensuring every required component was included.
The review identified a missing post-market surveillance plan and gaps in the risk file, which were corrected prior to audit — saving the client from major non-conformities and months of delay.