Technical Files That Tell a Story.
A DHF shouldn't be a pile of papers. It should be a logical story of safety and efficacy. We build or remediate your Design History File (DHF) to withstand any audit.
DHF Remediation
We fix legacy files. If your traceability matrix is broken or your validation reports lack conclusions, we rebuild them.
General Safety & Performance
For MDR, we map your evidence directly to the GSPR requirements (Annex I), ensuring no clause is left unsupported.
Traceability
We link Requirements → Risk → Design → Verification → Validation. The 'Golden Thread' auditor trail.
Engineers, Not Just Writers.
Technical Competence
Our team includes Biomedical and Software engineers who understand your schematics and code.
Live Link Integration
We can build your DHF inside our 'Live Link Tech File' software for permanent, dynamic control.
Audit Support
We stand by our work. If an auditor questions a file we wrote, we help you draft the defense.
Document Creation Process
Audit & Plan
We inventory your existing records and identify missing links.
Authoring
We interview your engineers to write protocols, reports, and specifications.
Review & Sign
You review for technical accuracy, we review for regulatory compliance. Then we sign.
Key Deliverables
Frequently Asked Questions
Do you create the test data?
No, you execute the tests. We write the protocols and format the final reports.
What about Software?
Yes, we specialize in IEC 62304 documentation for SaMD and SiMD.
Is this for FDA or CE?
Both. We create a 'Global Technical File' that satisfies both requirements.