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Engineering services for MedTech products and production

Four service lines and the engineering scope behind them, from product development to qualified production.

01 Fit

Where we help

We support R&D, QA and production teams with a defined work package or a complete project, from early development to released production.

  1. Product development

    Mechanical design, electronics and PCB, firmware and prototypes for medical devices, test equipment and production equipment.

  2. Verification and test engineering

    Test planning and test methods, test stands and fixtures, GR&R/MSA, test execution and V&V documentation.

  3. Production and qualification

    Industrialization, troubleshooting and improvement of equipment, DQ/IQ/OQ/PQ, FAT/SAT, CSV/CSA and audit-ready evidence.

02 Scope

Engineering scope

The engineering areas we cover for MedTech and regulated manufacturing. Each project is staffed with the engineers the agreed scope requires.

  1. 01

    Mechanical engineering and product development

    Mechanical design in CAD, prototypes and design documentation for medical device subsystems, test fixtures and production equipment.

  2. 02

    Electronics and PCB development

    Circuit and PCB design, firmware, design for IEC 60601 safety and EMC, and electronics testing. Led in-house by Patrick Keller, with more than ten years of MedTech electronics experience.

  3. 03

    Verification and validation (V&V)

    Product V&V: test planning, test methods and test equipment, test execution and documentation with traceability to requirements.

  4. 04

    Industrialization and production transfer

    Moving a design from development into production: manufacturing documentation, equipment and test setup, and handover to the production team.

  5. 05

    Manufacturing engineering and production improvement

    Troubleshooting and improving existing equipment and processes, fixtures and automation, with documented changes.

  6. 06

    Equipment and process qualification

    Qualification of production equipment and processes, including DQ/IQ/OQ/PQ and FAT/SAT where relevant: risk-based scope, protocols, execution support and reports.

  7. 07

    Software quality engineering and CSV/CSA

    Risk-based CSV/CSA for software and connected systems that support product development and regulated manufacturing.

03 Service lines

Services

Four 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

Development of medical device subsystems and engineering equipment, from concept and prototypes to design documentation ready for verification and production transfer.

  • Mechanical design and CAD, prototypes
  • Circuit and PCB design, embedded firmware
  • Design for IEC 60601 safety and EMC, pre-compliance testing
  • Verification planning and test execution
  • Design documentation and transfer to production

Certification testing is performed by accredited test laboratories. We prepare the design, the test evidence and the documentation for it.

See service details Meet the team

Service B

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
  • Test methods and GR&R/MSA for the measurement equipment used in qualification
See service details See example project

Service C

Test Stands / Fixtures (Mechatronics + Embedded)

Electromechanical test solutions for verification and manufacturing, from rapid prototype to documented equipment.

  • Fixtures, jigs, small test stands for verification/manufacturing
  • Motion (steppers/servos), sensors, safety interlocks
  • Embedded control, data logging, operator UIs
  • Custom electronics and PCBs designed in-house
  • 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

Service D

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

Focused service pages

Contact to start

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

04 Problems

Engineering problems we solve

Execution-focused engineering for regulated manufacturing, connected systems and device development.

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).

Request a CSV / CSA Gap Check

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 we 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

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, we 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

Discuss a project

Send 2–3 lines about what you are developing, testing or qualifying. We reply within 24 hours.

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