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

Regulatory

Our services

Quality

• 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.

• 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

Clear consulting. From concept to commercialisation.

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