TechkratesTransfer of a design to production
Production documents, assembly and test instructions, pilot series.
Production fileWork instructionsPilot run
Industrialization and production equipment for MedTech manufacturing
From a working prototype to a product production can build and test: transfer documents, assembly fixtures, semi-automatic stations and special machines, made safe and ready for CE.
- ISO 12100
- ISO 13849-1
- IEC 60204-1
- Machinery Regulation
- ISO 13485
Typical tasks
From the prototype to the station on the line.
An assembly fixture or semi-automatic station
Specified, designed and built with partner workshops, then brought up on site.
ConceptBuildCE file
Equipment concept for capex approval
A short paid study for a new station or machine that ends in the document for your budget decision.
URSConceptRisk analysisBudget
Machinery safety and CE for in-house equipment
Risk assessment, safety functions and the technical file for equipment you build yourself.
Risk assessmentSafety functionsTechnical file
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
Two cleanroom production machines qualified from DQ to PQ in two months, FAT and SAT included.
From our founder's track record. Larger machines are built by machine builders; we write the URS and the acceptance criteria and accompany the supplier.
Standards we work with
- ISO 12100
- Risk assessment of machinery
- ISO 13849-1
- Safety-related parts of the control
- IEC 60204-1
- Electrical equipment of machines
- 2006/42/EC, (EU) 2023/1230
- Machinery Directive and Regulation
- ISO 13485
- Process validation for production
The new EU Machinery Regulation applies from 20 January 2027. Equipment designed now should already follow it.
FAQ
Questions we hear first.
Do you build machines?
We specify, design and supervise the build with partner workshops and machine builders. For larger machines we write the URS and the acceptance criteria and accompany the supplier through FAT and SAT.
Do you work outside MedTech?
Yes. Machine builders, precision and contract manufacturers, lab and analytical instruments, optics and sensors, with the same engineering and documentation. See engineering for other industries.
What does the capex study cost?
From CHF 3 900, one to two weeks. The documents carry over into the DQ when the equipment is built.
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