TechkratesOne design verification test, protocol to report
Test method, sample size, fixture, execution and a report QA can sign.
ProtocolFixtureRaw dataReport
Design verification and testing for medical devices
A design verification test from protocol to report, in your lab or on a test stand we build for it. Every result traced to a requirement, in your templates.
- ISO 13485 7.3.6
- ISO 14971
- IEC 60601-1
- ISO 11608
- IEC 62366-1
Typical tasks
From one test to the whole verification campaign.
Test method validation and GR&R
Prove the method measures what it should, before the samples run.
TMV reportGR&R studyMethod SOP
Verification plan and traceability
Requirements, tests and acceptance criteria linked in one matrix.
V&V planTrace matrixGap list
Re-verification after a design change
Only the tests the change touches, with a written rationale.
Impact assessmentDelta testsReport
How we start
From the first call to the documents, in four steps.
Work starts within a week of the offer.
- 30 minutes
Scope call
The device, the task, the deadline and your quality system.
Call notes - Within 2 days
Fixed offer
Deliverables, price and dates on one page.
Offer · plan - Start within a week
Work
Design, build and test, with a short status every week.
Weekly status · reviews - At the end
Handover
Everything in your templates, ready for your DHF and your production.
Drawings · reports · files
Proof
Design verification of autoinjectors at Ypsomed, with the test stands, fixtures and cobot integration the tests needed.
From our founder's track record.
Standards we work with
- ISO 13485
- Design verification, clause 7.3.6
- ISO 14971
- Risk-based sample sizes and acceptance
- IEC 60601-1
- Safety tests for electrical devices
- ISO 11608
- Needle-based injection systems
- IEC 62366-1
- Usability verification inputs
Certification tests run at accredited labs. Verification in your lab or on our stands comes first, so the lab confirms.
FAQ
Questions we hear first.
Where are the tests run?
In your lab with your equipment, or on a test stand we design and build for the test. Certification tests go to accredited labs.
Do you write the protocols in our templates?
Yes. Protocols, raw data and reports follow your SOPs and document numbering.
Can you verify to ISO 11608?
Yes, for needle-based injection systems: functional tests such as dose accuracy, forces and timing, based on autoinjector verification work.
Do you sign an NDA, and who owns the results?
Yes. Techkrates signs your NDA before the first technical details, and the designs, documents and data made for your project belong to you.
In which language are the documents?
German or English, in your templates and your document numbering.
Send two or three lines about the device and what you need.
An engineer answers within 24 hours. At a fixed price per task or from CHF 950 per day.
- Company
- Techkrates, Zurich
- On site
- Switzerland and Germany
- Languages
- English, German
- Contact