Service A
Product development: mechanical, electronics, firmware
- Mechanical design and CAD, prototypes
- Circuit and PCB design, embedded firmware
- Design for IEC 60601 safety and EMC
Swiss engineering for MedTech products and their production
Techkrates takes on development, test equipment, verification, industrialization and the qualification of production equipment and processes, as a defined project at a fixed price or as engineering capacity inside your team. On site in Switzerland and Germany, remote across Europe.
From our founder’s track record:
- Qualified two cleanroom production machines from DQ to PQ, including FAT and SAT
- Design verification of autoinjectors
- IVD instrument hardware at Agilent
Also for special machinery, lab and precision equipment
Led by founder Filip Jaromczyk, with one technical lead from the first call to handover and documentation that holds up in QA and regulatory review. Electronics and firmware are developed with partner engineers, among them Patrick Keller, who has more than ten years in MedTech electronics.
- Location
- Zurich, Switzerland • On-site in Switzerland and Germany
- Languages
- English / German
- Disciplines
- Mechanical • Electronics & PCB • Firmware • Test stands & fixtures V&V • Industrialization • DQ/IQ/OQ/PQ • FAT/SAT • CSV/CSA • IEC 60601 • IEC 62304
Techkrates
2 months
Two new cleanroom production machines qualified for a Swiss medical device manufacturer, DQ to PQ including stability testing. Planned and run by Filip Jaromczyk, who also wrote the FAT and SAT.
15 years
Filip's experience in engineering, seven of them in MedTech. Electronics partners add more than ten years in MedTech electronics.
Ypsomed & Agilent
Agilent: Filip was Design Responsible for an IVD pathology instrument. Ypsomed: design verification of autoinjectors, plus test stands, fixtures and cobot integration.
24 h
Reply time for every project inquiry
01 Services
Services
Six service lines. Each can be booked as a defined package, combined in one project with a single technical lead, or staffed as engineering capacity inside your team.
Service B
Equipment Qualification (DQ / IQ / OQ / PQ) + FAT/SAT
- Risk-based qualification strategy and protocols
- FAT/SAT acceptance criteria and execution support
- QA-ready reports and evidence packages
Service C
Test Stands / Fixtures (Mechatronics + Embedded)
- Fixtures, jigs and small test stands
- Motion, sensors, control electronics, data logging
- GR&R/MSA and documentation for later validation
Service D
CSV & CSA for Product and Manufacturing Support Systems
- Risk-based validation tied to intended use
- Test plans, scripts, traceability, data integrity
- Change impact assessments and re-validation
Service E
Sustaining engineering (Design Responsible as a service)
- ECR/ECO, change impact assessment, DHF updates and traceability
- Obsolescence and technical changes at the contract manufacturer
- Legacy platform modernization, IEC 62304 verification of software changes
Service F
Engineering capacity on contract
- An engineer in your team, one to five days a week, for one to twelve months, on site or remote
- Verification and test, qualification and validation, mechanical design, industrialization
- Billed by the day, from CHF 950 per day, invoiced monthly, no recruitment fee
02 Projects
Projects
Concise, anonymized case studies focused on engineering outcomes.
Qualification of two new cleanroom production machines
- Problem
- Two machines needed release with clear acceptance criteria and evidence for DQ/IQ/OQ/PQ.
- Approach
- Qualification plan and DQ/IQ/OQ/PQ protocols, FAT/SAT and cleanroom execution support, part corrections during qualification, tests across all product combinations, PQ with stability testing.
- Outcome
- Both machines qualified within two months, with fewer deviations and a clean QA evidence package.
CSV → CSA for a Connected Device Add-On (US-bound)
- Problem
- A connected hardware add-on with cloud services had to be validated in a US-bound / FDA context, with frequent changes.
- Approach
- Risk-based CSV, traceability across HW/SW, structured change impact assessments and a gradual transition to CSA.
- Result
- Audit-ready evidence across integrated components and faster iteration cycles.
03 Company
Team
An engineering company in Zurich with one technical lead for each project and engineers assigned by discipline.
One technical lead per project, and the engineers each discipline needs.
Mechanical design, test equipment, verification and qualification are delivered by Techkrates. Electronics and firmware are developed with partner engineers, among them Patrick Keller, and specialist partners join for work such as PLC/SPS integration or machining when a project needs it.
You keep one technical contact from the first call to handover, whether we deliver a defined project or work as engineering capacity inside your team.
Founder • Project lead
Filip Jaromczyk
Mechanical/mechatronics engineer focused on regulated hardware in MedTech manufacturing. At Agilent, Design Responsible for an IVD pathology instrument. At Ypsomed, design verification of autoinjectors, plus test stands, fixtures and cobot integration. For a Swiss medical device manufacturer, planned and ran the DQ to PQ qualification of two production machines and wrote the FAT and SAT.
- Qualification: URS through DQ/IQ/OQ/PQ to cleanroom execution and QA-ready reports
- Test stands, fixtures, automation and prototypes
- ISO 10993 biocompatibility and FDA 21 CFR 820 (QMSR)
- Traceability, risk management, ECO/ECR, obsolescence
PK
Electronics partner
Patrick Keller
Partner engineer for electronics, with more than ten years in MedTech electronics development. Covers the complete electronics workflow, from requirements to tested and documented hardware.
- Circuit design and PCB layout
- Embedded firmware
- Design for IEC 60601 safety and EMC, pre-compliance and verification testing
- Usability engineering to IEC 62366-1
Key standards: ISO 13485 • ISO 14971 • FDA 21 CFR 820 (QMSR) • IEC 60601-1 / -1-2 • IEC 62366-1 • IEC 62304 • ISO 10993 • GAMP 5 Full list
04 Process
How we work
Four steps that keep the work focused and give QA and engineering what they need.
Clarify the outcome
Lock requirements, constraints and acceptance criteria.
Plan & de-risk
Risk-based plan, test strategy, documentation map and team assignment.
Execute & document
Design, build, test and qualify, with protocols, evidence, deviations and reports.
Handover
Clean package + recommendations for production, requalification and maintenance.
Start small
Low-risk first steps that clarify the work and produce tangible outputs.
- Qualification Gap Check Result within 3 working daysfrom CHF 750 Prioritized gap list and recommended path to DQ/IQ/OQ/PQ.
- FAT/SAT Acceptance Pack Result within 1 weekfrom CHF 1 500 Acceptance criteria, checklist and punch-list template.
- CSV / CSA Gap Check Result within 1 weekfrom CHF 1 500 Gap assessment and risk-based validation strategy.
- CSV/CSA Criticality & Risk Review Result within 3 working daysfrom CHF 950 Criticality map and testing/evidence path.
- Test Bench / Fixture Sprint 1 weekfrom CHF 5 500 Concept, architecture, rough BOM and validation path.
- Equipment Concept for Capex Approval 1 to 2 weeksfrom CHF 3 900 URS, concept, risk analysis, budget and schedule for your capex approval.
- Capacity on contract First week at the day rate, then month by monthfrom CHF 950 per day An engineer in your team for verification, qualification or mechanical design, on site or remote.
First steps have a fixed price and a fixed delivery date, agreed in writing before the start. Capacity on contract is billed by the day and invoiced monthly.
05 Insights
Insights
Practical, engineering-first notes for MedTech teams, focused on evidence, boundaries and execution.
- Process validation for MedTech suppliers: DQ, IQ, OQ and PQ in practice When validation is required, what each stage proves, and why a PQ needs several operators. Read the article
- Windows CE to Windows 10 IoT (IEC 62304): migration checklist Senior-engineer playbook with system boundaries, evidence checklist and cybersecurity workstream. Read the article
- Omron D6F airflow safety system: root causes and fixes Why production installs failed: turbulence, placement bias, scaling, and redundancy logic. Read the article
06 Contact
Contact
Send 2–3 lines about your project, or about what is blocking release, qualification, testing or production handover. We reply within 24 hours with whether we can help and the most practical next step.
Direct
- [email protected]
- Phone
- +41 783 20 66 33
- Chat on WhatsApp
- Filip Jaromczyk • Techkrates