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MedTech qualification, validation and test engineering support when release is blocked

I help MedTech teams qualify equipment, close FAT/SAT and CSV/CSA gaps, build test fixtures, and produce audit-ready evidence when production handover, release or verification work is stuck.

Send the bottleneck See services

Based in Zurich • Serving Switzerland • On-site & remote

English / German

DQ/IQ/OQ/PQ • FAT/SAT • Commissioning • Test Stands & Fixtures Verification (GR&R/MSA) • CSV (Computer System Validation)/CSA • Embedded (Arduino/STM32) • Audit-ready Evidence

Founder-led, hands-on engineering support from Zurich. Filip personally leads the technical work; for larger scopes, Techkrates scales through a trusted specialist network.

Where I help fastest

Best fit when QA, R&D or Production has a concrete bottleneck and not enough specialist engineering bandwidth to remove it.

Qualification / validation bottlenecks

DQ/IQ/OQ/PQ, FAT/SAT, CSV/CSA, missing evidence, unclear acceptance criteria, supplier documentation gaps.

Test engineering and fixtures

Verification rigs, test stands, jigs, measurement repeatability, GR&R/MSA, data logging, practical automation.

Production handover and prototypes

Prototype-to-production gaps, troubleshooting, equipment retrofit, documentation cleanup, engineering bandwidth.

Engineering problems I solve

Short, execution-focused manufacturing engineering fixes for regulated manufacturing and connected systems.

Engineering Work (Hands-on)

Hands-on execution for field issues, retrofit work, and verification rigs — NDA-safe, evidence-ready.

Field issue / retrofit sprint

Problem: Field issues demand fast root-cause analysis, an equipment retrofit, and verification evidence.

Typical signals:

  • Service events, scrap, or alarms with unclear failure mode
  • EOL components forcing a retrofit under time pressure

What I deliver:

  • Root-cause analysis, design fix, and verification plan
  • Retrofit change package with updated evidence

See retrofit project snapshot

Sensors & measurement systems

Problem: Sensor integration behaves differently in the field than in the lab.

Typical signals:

  • Offsets drift after installation or across temperature
  • Redundancy logic trips without a clear failure mode

What I deliver:

  • Integration + calibration logic with failure-mode checks
  • Verification plan and evidence updates for QA

See Omron D6F case

Mechanical/mechatronics prototyping

Problem: A fixture or verification rig prototype has to work quickly.

Typical signals:

  • No test setup to validate the design
  • R&D needs data before design freeze

What I deliver:

  • Rapid fixture/rig prototype with controlled IO + logging
  • Path to industrialization with documentation notes

See prototyping service

Manufacturing equipment robustness

Problem: Production equipment instability hurts throughput and quality.

Typical signals:

  • Downtime, scrap, or yield drift under normal conditions
  • Process window not tied to evidence

What I deliver:

  • Stabilization plan with root-cause and retrofit actions
  • Manufacturing engineering changes with QA-friendly evidence

See equipment qualification support

Embedded change impact (IEC 62304-aware)

Problem: Small embedded changes trigger large re-validation scope.

Typical signals:

  • Firmware/library updates ripple into safety evidence
  • Embedded change impact is unclear across components

What I deliver:

  • Change impact assessment and IEC 62304 evidence mapping
  • Test strategy aligned to submission-driven evidence

See IEC 62304 migration insight

Test method + repeatability (GR&R/MSA)

Problem: Test method is not repeatable on real hardware.

Typical signals:

  • GR&R/MSA fails due to fixture variability
  • Manual measurements drift between operators

What I deliver:

  • Test method definition with acceptance criteria
  • Repeatability improvements and verification rig tuning

See GR&R/MSA insight

If late requirements, cybersecurity, and testability are inflating scope, see verification-driven engineering in MedTech.

Services

Three focused offers with a clear front door: Qualification + FAT/SAT first, supported by engineering and CSV/CSA.

Primary track

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

Audit-ready protocols, execution support, and evidence packs to release equipment confidently.

  • URS/requirements review & gap list
  • Risk-based qualification scope
  • DQ / IQ / OQ / PQ protocols (as applicable)
  • FAT/SAT acceptance criteria + punch-list support
  • Execution support + deviations log
  • QA-friendly reports + evidence package
  • Verification test methods, GR&R / repeatability checks, evidence capture
See service details See example project

Secondary track

B) Test Stands / Fixtures (Mechatronics + Embedded)

Rapid prototyping of electromechanical test solutions designed to scale.

  • Fixtures, jigs, small test stands for verification/manufacturing
  • Motion (steppers/servos), sensors, safety interlocks
  • Embedded control (Arduino/STM32), data logging, simple UIs
  • Basic PCB design when needed
  • Documentation bridge to regulated needs (what to validate later, what evidence to capture)

PLC/SPS integration via partner network when required.

See service details See example project

Specialist track

C) CSV & CSA for Product and Manufacturing Support Systems

Risk-based CSV/CSA for software and connected systems that support product development and regulated manufacturing. Focused on intended use, data integrity, and audit-ready evidence — without document-heavy overhead.

  • Validation planning for complex software and integrated HW/SW systems
  • Risk-based scope tied to intended use and system criticality
  • Test plans, scripts, and evidence capture for key workflows
  • Requirements-to-test traceability and data integrity focus
  • Change impact assessments and re-validation strategy

Aligned with FDA CSA guidance and GAMP 5 (2nd edition) context.

See service details See example project
Contact to start

If late requirement shifts are inflating scope, this explains the pattern and how to avoid it: Verification-driven engineering in MedTech .

How I work

Four steps that keep scope tight and make QA/Engineering happy.

Clarify the outcome

Lock requirements, constraints and acceptance criteria.

Plan & de-risk

Risk-based scope, test strategy and documentation map.

Execute & document

Protocols, evidence, deviations and reports.

Handover

Clean package + recommendations for requalification/maintenance.

Pricing guidance

Predictable scope & transparent change control.

Approach

Every project is scoped individually. Most clients start with either a short fixed-scope package or a time-based engagement for execution support.

How you avoid surprises: We agree on scope, deliverables and acceptance criteria upfront. Any change is handled as a clear change request.

What drives cost (and how we control it)

  • Equipment complexity & criticality (risk-based scope)
  • Documentation maturity (URS, drawings, calibration records)
  • Execution model (documentation-only vs co-execution vs full execution)
  • On-site needs (cleanroom access windows, shifts, travel)
  • Iterations / change requests (handled as clear change requests)

Start small

Low-risk first steps that clarify scope and produce tangible outputs.

CSV / CSA Qualification Gap Check (Fixed Scope)

Short, focused engagement to assess validation gaps and define a practical, risk-based path forward (typically 1–2 working days).

When this is a good fit

  • Legacy or under-documented software systems
  • Upcoming audit, inspection, or internal QA review
  • Complex software or integrated HW/SW systems
  • Transition from traditional CSV to modern CSA

What you get (deliverables)

  • Structured gap assessment against intended use and criticality
  • Prioritized list of risks and missing evidence
  • Recommended validation / assurance strategy (CSA-aligned)
  • Clear next-step options (documentation, testing, remediation)

What I need from you

  • Basic system description and intended use
  • Existing specifications and test evidence (if available)
  • Access to key stakeholders (QA / Engineering)

Outcome

  • Clarity on validation scope
  • Reduced audit risk
  • Actionable plan instead of generic documentation
Request a CSV / CSA Gap Check

Qualification Gap Check (2–4 hours)

Rapid review of URS/specs + available vendor docs; you get a prioritized gap list and a recommended path to DQ/IQ/OQ/PQ (scope by criticality).

Outputs
  • Prioritized gaps & missing evidence
  • Recommended qualification path (DQ/IQ/OQ/PQ)
  • Next-step plan (what to do first)

FAT/SAT Acceptance Pack (6–10 hours)

Acceptance criteria + checklist aligned to your URS and risks; includes a punch-list template to drive clean close-out with the vendor.

Outputs
  • Acceptance criteria
  • FAT/SAT checklist
  • Punch-list template + close-out structure

Test Bench / Fixture Sprint (1–2 weeks)

A practical concept for a fixture, verification rig or small test bench: requirements, measurement method, sensor/control architecture, risk list, rough BOM and validation path. If the concept makes sense, Techkrates can also build and document the system.

Outputs
  • URS-lite with draft acceptance criteria
  • Mechanical / measurement / control architecture
  • Risk list, rough BOM and build plan
  • Validation and evidence path for QA handover

CSV/CSA Scope & Risk Review (4–8 hours)

Criticality map + validation approach for a system with data flows and dependencies; you get a clear testing/evidence path (CSV now, CSA where appropriate).

Outputs
  • Criticality / risk map
  • Proposed validation approach (CSV/CSA)
  • Test/evidence path for key workflows & data integrity

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.

What I did: Built the qualification plan, wrote DQ/IQ/OQ protocols, and supported FAT/SAT and cleanroom execution.

Outcome: Faster release with fewer deviations and a clean QA evidence package.

Pulling machine prototype for materials testing

Problem: R&D needed a rapid prototype to de-risk a process and generate repeatable measurements.

What I did: Designed and built the rig with Arduino control, stepper motor, linear stage, IR lamp, and pneumatics.

Outcome: Reliable test data and a clear path to industrialization.

Collaborative robotics for verification automation

Problem: Manual verification steps were slow, variable, and difficult to scale.

What I did: Defined fixtures and sequences for an Omron cobot workflow with test automation and evidence capture.

Outcome: Improved repeatability and throughput with cleaner verification records.

CSV → CSA for a Connected Device Add-On (US-bound)

Problem: A connected hardware add-on plus multiple software services (incl. cloud/data flows) had to be validated in a US-bound / FDA context. The system had many dependencies and frequent changes, requiring repeated validation cycles.

Approach: Risk-based CSV delivery (scope by criticality), traceability across HW/SW, test scripts and evidence capture for key workflows and data integrity, dependency mapping, structured change impact assessments and re-validation. Over time, transitioned the validation approach toward CSA to keep pace with changes while preserving audit-ready evidence.

Result: Audit-ready validation evidence across integrated components, faster iteration cycles, and clearer change control for a complex connected system.

Read full case

Insights

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

Windows CE to Windows 10 IoT (IEC 62304): migration checklist

Senior-engineer playbook with scope 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

IQ vs OQ in practice: What evidence counts (and what does not)

How to keep installation and operational evidence clean, traceable, and audit-ready.

Read the article

FAT vs SAT: Acceptance criteria that prevent surprises

Define measurable criteria and use a punch-list workflow that closes gaps before qualification.

Read the article

CSA explained for MedTech: Fewer tests, not less safety

Risk-based assurance that reduces low-value testing without reducing evidence quality.

Read the article

Qualification documentation gaps that delay equipment release

Common gaps in drawings, specs, and work instructions — and how to close them fast.

Read the article

CSV/CSA for connected HW/SW systems: Scope, traceability, test strategy

Practical boundaries and evidence planning for connected devices, cloud, and mobile apps.

Read the article

Designing test stands for repeatability: GR&R and MSA

Engineering choices that make test data trustworthy in real projects.

Read the article

Case snapshots

Anonymized, NDA-safe examples focused on problem, approach, and result.

Equipment qualification close-out in regulated manufacturing

Problem

  • Two production machines required DQ/IQ/OQ evidence for release
  • Documentation and evidence maturity were inconsistent across systems

Approach

  • Built qualification protocols and reports aligned to risk
  • Defined stability testing and a clear qualification gap list
  • Delivered CSV plan and report to align software evidence

Result

  • Clear visibility of qualification gaps
  • Faster close-out and improved audit readiness

Documentation, schematics, and work instruction remediation

Problem

  • Missing component specifications and outdated schematics
  • Machine and process work instructions were inconsistent

Approach

  • Rebuilt electrical and pneumatic schematics to match as-built state
  • Updated component specifications and revision control
  • Rewrote machine and process work instructions with QA input

Result

  • Stronger IQ baseline and fewer deviations in execution
  • Audit-ready documentation package

R&D electromechanical test stand prototype

Problem

  • Need to explore a wider range of manufacturing parameters
  • Integration issues across firmware, motion control, and repeatability

Approach

  • Designed and built a custom electromechanical test stand
  • Stabilized motion control and measurement methods
  • Applied repeatability checks to lock in usable data

Result

  • Working, repeatable test stand for R&D use
  • Improved ability to explore and validate parameters

CSV/CSA support for a complex connected system

Problem

  • Connected ecosystem with embedded device, cloud, and mobile apps
  • Audit, upgrade, and rollout activities ahead of a submission

Approach

  • Defined specifications, CSV plan, and risk-based test strategy
  • Executed tests, reporting, and traceability matrix
  • Supported SDK and component-level validation

Result

  • Audit-ready evidence across integrated components
  • Clearer change impact and validation path for upgrades

About

Short, no fluff.

Profile photo
  • Mechanical/Mechatronics engineer focused on regulated hardware in MedTech manufacturing.
  • Hands-on delivery: from requirements/URS through DQ/IQ/OQ/PQ to cleanroom execution and QA-ready reports.
  • Pragmatic test solutions: fixtures, jigs, automation, prototypes.
  • Typical tech: CAD design, basic PCB design, Arduino/STM32, steppers/servos, sensors, pneumatic interfaces, data logging & simple UIs.
  • Based in Zurich, operating Switzerland-wide when needed.
  • Experience: traceability, risk management, ECO/ECR, obsolescence.
  • Regulated mindset: tight scope, evidence-based, traceable.
  • Languages: English/German.
  • Best fit when internal QA, R&D or Production teams have a concrete bottleneck but not enough specialist engineering bandwidth.

Boutique engineering studio. Most work is led directly by Filip. When the scope requires it, Techkrates can add trusted specialists for mechanical design, embedded, PCB, machining, automation or documentation support. PLC/SPS integration via partner network when required.

Focus

Equipment qualification (DQ/IQ/OQ/PQ) • FAT/SAT support • Commissioning support • Verification (GR&R/MSA) • Test stands/fixtures & jigs • Automation • Robotics (cobots) • Prototypes • Productivity improvements

Environment

MedTech / biotech manufacturing • regulated • cleanroom / production

Standards

ISO 13485 • ISO 14971 • IEC 60601 • IEC 62304 • ISO 11608 • ISO 14644 • ISO 12100 • ISO 13849-1 • IEC 60204-1 • 21 CFR Part 11 • EU GMP Annex 11 • GAMP 5 • MDR • IVDR

Contact

Send 2-3 lines about what is blocking release, qualification, testing or production handover. I reply within 24 hours with whether I can help and the most practical next step.

Send a message