Risk-based Verification & Validation for medical devices. From strategy to execution.

Fen MedTech helps funded medtech teams turn unclear or fragile V&V plans into defensible, regulator-ready evidence strategies for Class II & III medical devices.

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Does this sound familiar?

Prototype → verification: you cannot clearly justify what you are testing, why, and how it links to requirements and risk.

Manufacturing ramp-up: IQ/OQ/PQ is behind schedule, inconsistent, or not audit-ready.

Test methods: methods exist, but TMV is missing, so results are hard to defend.

Services

  • A short, focused engagement to bring clarity to your verification and validation approach.

    What Fen MedTech does

    • Review requirements, risk management file, and existing verification plans

    • Identify gaps, misalignment, and unnecessary testing

    • Prioritise evidence based on risk and regulatory expectations

    What you get

    • A clear V&V roadmap linked to requirements and risk

    • Prioritised testing plan with rationale

    • Draft list of required protocols and TMV activities

  • Hands-on execution of verification and test method work where teams need momentum and defensible results.

    What Fen Medtech does

    • Develop and validate test methods (TMV)

    • Design or refine fixtures and rigs where needed

    • Author and execute verification protocols

    • Perform statistical analysis and interpret results

    What you get

    • Executed, traceable verification evidence

    • Validated test methods you can reuse with confidence

    • Clear, audit-ready reports

  • Practical process validation support as devices move toward manufacture or scale-up.

    What Fen MedTech does

    • Plan and execute IQ/OQ/PQ for equipment and processes

    • Perform process characterisation and capability studies

    • Define process windows and acceptance criteria

    • Support validation documentation, deviations, and investigations

    What you get

    • Audit-ready process validation evidence

    • Clear understanding of process capability and risk

    • Validation documentation aligned to ISO 13485 expectations

Device experience

Fen MedTech has experience in verification, validation, and manufacturing support across a range of regulated medical technologies, including:

Robotic surgical instruments
Complex mechanical systems with tight tolerances, reusable life testing, and safety-critical performance requirements.

Active implantable devices
Process development, equipment validation, and verification work in ISO 13485 cleanroom environments.

Implantable medical devices
Risk-based verification, test method development, and evidence aligned to Class II/III regulatory expectations.

Biotech consumables (cell & gene therapy)
Verification and test engineering support for single-use and high-throughput consumables in regulated manufacturing contexts.

“invaluable”

— Former Customer

Get in Touch

If you are not sure whether this is a good fit, please get in touch anyway! Share a few details about your project or current challenges and I will review them and get back to you within 48 hours.