Map
Create the index, trace links and gap list across the file.
Tech Docs and Audit Prep
Technical documentation and evidence reviewers can navigate
Build a clear, linked set of records for audits and submissions. We assemble DHF, DMR, technical files, medical device files and map evidence, preparing your team for any audit questions.
Complete set
DHF, DMR or technical files/medical device files organized
DHF, DMR or technical files/medical device files organized
Clean traceability
From risk and requirements to tests
From risk and requirements to tests
Audit ready
Index, samples and talking points
Index, samples and talking points
Reviewer friendly
Consistent filenames and structure
Consistent filenames and structure
Scope
What we execute and what you receive
We connect design history, risk, verification and labeling so your file tells a consistent story from concept to release.
Documentation activities we run
- File structure and naming system aligned to your markets
- Evidence mapping across design, risk and verification
- Gaps closure plan and document creation or updates
- Labeling and UDI links to device and packaging
- Manufacturing and acceptance criteria alignment
- Mock auditor questions and response coaching
- Submission binder assembly for target pathway
Deliverables you bring to review
- Technical file, medical device file or DHF index with links and ownership
- Trace matrix that connects requirements and tests
- Risk files and verification reports with coverage view
- Label set, UDI details and artwork proofs
- Manufacturing section and acceptance records
- Audit day plan, roles and talking points
How it works
From gap list to confident audit day
We align activities with your device, team and deadlines so each week builds records and confidence.
Build
Close gaps, standardize evidence and align risk with tests.
Rehearse
Run a mock audit and finalize the binder and talking points.
FAQ
Common questions
Do we need a full file or can you focus on gaps?
We can assemble the full file or target gaps like risk alignment, verification coverage or labeling.
Can you prepare us for tough auditor questions?
Yes. We run a mock session with scenarios and create short answers that point to the right records.
Will you work in our document system?
Yes. We can build the structure in your eQMS or shared drive and keep ownership clear.
How do you keep filenames and versions consistent?
We apply a naming and version scheme, then lock it in with a simple index and change control.
Ready to finalize your documentation?
Book a quick call to align scope, timeline and deliverables so your next audit day runs smoothly.