IVD Simplicity has a range of consulting and training services covering regulatory, quality, product development and innovation to support you from product concept to commercialisation and beyond. Whether you are a start-up or an established small company, we provide flexible and customised solutions that are clear, no-nonsense and cost-effective.

  • Person Responsible for Regulatory Compliance (PRCC).

  • Product classification and regulatory strategy.

  • Performance evaluation planning and reporting, including scientific validity, analytical performance and clinical performance.

  • Risk management (ISO 14971).

  • Preparation of regulatory submissions in compliance with the UK MDR, EU IVDR and other global regulations.

  • Technical documentation review and remediation.

  • Review of marketing, product packaging, labelling and instructions for use to ensure compliance with global requirements.

  • Post-market surveillance and vigilance guidance.

  • Gap analysis.

  • On-site group training.

Our services


samples for in vitro diagnostic (IVD) testing
samples for in vitro diagnostic (IVD) testing

Our services


  • Identification of applicable standards.

  • QMS implementation, remediation and maintenance in conformity with ISO 13485, MDSAP and other global requirements.

  • Quality planning guidance, including quality objectives and management of changes to the QMS.

  • Quality impact assessment of design and development activities.

  • Manufacturing and QC documentation guidance.

  • Supplier control, including the control of critical outsourced processes.

  • Equipment and QMS software validation guidance.

  • Control of nonconformities, including root cause analysis, corrective action and preventive action.

  • Management review.

  • Internal auditing and gap analysis.

  • On-site group training.

automated in vitro diagnostic (IVD) test
automated in vitro diagnostic (IVD) test
  • Innovation input to new product concepts.

  • Evaluation of novel technologies for IVD applications.

  • Interpretation and analysis of scientific data for feasibility, development and verification/validation studies.

  • Design and development project planning and guidance from initial concept to market launch.

  • Generation of design and development documentation in compliance with applicable global quality and regulatory requirements.

  • Production and QC methodology development and troubleshooting.

  • Process and QC test method validation guidance.

  • Manufacturing process scale-up advice.

  • Management of design and development changes.

  • On-site group training.

Our services

Innovation and development

in vitro diagnostic (IVD) test development
in vitro diagnostic (IVD) test development

Clear consulting. From concept to commercialisation.

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