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MedTech engineering, verification and qualification, from prototype to released production

I am Filip Jaromczyk, and I run Techkrates in Zurich. I lead every project myself: mechanical design, test equipment, verification and the qualification of production equipment and processes, with documentation that holds up in QA and regulatory review.

Discuss a project See services

Also for special machinery, lab and precision equipment

Electronics is developed with Patrick Keller, who has more than ten years in MedTech electronics. For larger projects I put together a team of regular partners and remain your technical contact. Specialist partners join when a project needs them.

Techkrates
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

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, who also wrote the FAT and SAT.

10+ years

MedTech electronics development: PCB, firmware, IEC 60601, EMC

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

Five service lines. Each can be booked as a defined package or combined in one project with a single technical lead.

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
See details

Service B

Equipment Qualification (DQ / IQ / OQ / PQ) + FAT/SAT

  • Risk-based qualification scope and protocols
  • FAT/SAT acceptance criteria and execution support
  • QA-ready reports and evidence packages
See details

Service C

Test Stands / Fixtures (Mechatronics + Embedded)

  • Fixtures, jigs and small test stands
  • Motion, sensors, in-house electronics, data logging
  • GR&R/MSA and documentation for later validation
See details

Service D

CSV & CSA for Product and Manufacturing Support Systems

  • Risk-based scope tied to intended use
  • Test plans, scripts, traceability, data integrity
  • Change impact assessments and re-validation
See details

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
See details
All services and engineering scope

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.
Read full case
All projects

03 Company

Team

A founder-led engineering company in Zurich, with one technical contact for each project.

“I lead projects personally and assemble the engineering team needed for the agreed scope.”

Filip Jaromczyk, founder

I lead every project myself. Electronics is developed with Patrick Keller, and specialist partners join for work such as PLC/SPS integration or machining when a project needs it.

You have one technical contact from scoping to handover.

Filip Jaromczyk

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
Full profile LinkedIn
PK

Electronics engineering lead

Patrick Keller

Electronics engineer 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
Full profile

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 scope tight and make QA/Engineering happy.

  1. Clarify the outcome

    Lock requirements, constraints and acceptance criteria.

  2. Plan & de-risk

    Risk-based scope, test strategy, documentation map and team assignment.

  3. Execute & document

    Design, build, test and qualify, with protocols, evidence, deviations and reports.

  4. Handover

    Clean package + recommendations for production, requalification and maintenance.

Start small

Low-risk first steps that clarify scope 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 Scope & 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.

Fixed price and fixed delivery date, agreed in writing before the start.

Discuss a first step Details for each first step

05 Insights

Insights

Practical, engineering-first notes for MedTech teams, focused on evidence, scope, and execution.

All insights

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

Send a message