MEDICAL DEVICE QUALITY & TRACEABILITYTechnical file review
Find the record behind the file.
See the document behind a finding, the revision used and the information that is still missing.
Explore the sample →Medical device quality & documentation
Every record.
In the right place.
Nitelis brings requirements, risk, design and test records into one review. Follow the records that need another look when a document changes.
DOCUMENT REVIEW WITH NITELIS
Where would you like to start?
A clear technical file starts with a closer look at each record.
Revision comparison
Follow a changed requirement.
Reassess the linked design, risk control and test records when a requirement changes. Keep earlier results separate from the new revision.
Explore the sample →Review record
Prepare for the review meeting.
Review open findings alongside their sources. Add a reviewer and target date, then export the review record.
Explore the sample →USE CASES
Built around everyday
quality work.
We are developing Nitelis for teams that need to review records held across different documents.
MDR technical documentation
Track supporting documents and missing records for each review item. Keep every finding connected to its source.
ISO 13485 quality records
Review current version relationships across procedures, design inputs and review records.
Design change
Inspect how a change affects risk controls, design and test results. Identify what needs reassessment.
The product is in development. The sample below demonstrates the intended review flow with fictional records.
A WORKING EXAMPLE
One line changes.
Three records need review.
An alert threshold changes from two seconds to one. Are the earlier risk control, design and test records still applicable?
Open the example and follow the impact through the source records.
Start the reviewChange review recordFictional record · REQ-014
Previous requirement2 seconds
Current requirement1 second
RISK-007Needs review
DES-021References old version
TEST-008No new test result
A test passed against an earlier revision does not verify the new one.
ABOUT US
Why Nitelis?
Requirements, risk records and test results often live in different places. When one document changes, the team has to revisit the others and ask the same questions again.
We are building Nitelis to make that review easier: following links without losing document sources and versions, while making gaps and open work clear.
Our first step is a working sample from requirement to verification. Document analysis and AI assistance are the next steps in our development plan.
PLANS
Built around your team’s needs.
Try the sample today. Discuss the scope of our planned commercial packages with us.
Sample workspace
FreeA fictional review with no account required.
- Revision comparison
- Source record inspection
- Review export
Team
Request a quotePlanned package · Early access
- Document and revision tracking
- Requirement–test links
- Team review workflows
Enterprise
Request a quotePlanned package · Early access
- Organization-specific scoping
- Integration needs assessment
- Pilot planning
Team and Enterprise packages are in development and cannot be purchased yet. Pricing, scope and availability will be confirmed in a proposal.
YOUR QUESTIONS
Frequently asked questions
A few things to know before you start.
Can I try Nitelis today?
Yes. The sample is free and needs no account. Review a fictional requirement change, open source records and export your review. Customer document upload is not available yet.
Who is it for?
Medical device quality, regulatory and R&D teams, particularly those working across technical documentation, design changes and verification records.
Do you issue MDR or ISO 13485 certificates?
No. Nitelis is a document-review software project. It does not provide certification or replace conformity assessment and approval decisions.
Where will AI be used?
We plan to use AI to assist document classification, structured extraction and change review, with source references accompanying suggestions. The current sample does not use AI.
Do I need to upload documents?
No. The sample uses fixed fictional records and needs no upload or account. Review inputs stay in browser memory and reset when the page reloads.
How will pricing work?
The sample is free. Commercial pricing has not been set; pilot scope and terms will be announced separately.
CONTACT & PILOT STUDIES
How does your team work?
Where does your team spend the most time in technical file reviews? Our pilot studies will focus on understanding real workflows and shaping the product around them.