Quality, Regulatory and Clinical Compliance Services

APIS offers a Quality, Regulatory and Clinical Affairs consultancy service to help navigate the IVD regulatory environment across different regions (including CE-IVDR, UKCA and FDA). Our dedicated Quality, Regulatory and Clinical Affairs teams will work closely with you to ensure compliance, providing cost effective and efficient support wherever necessary.

Our Compliance Services can provide you with:

  • Clinical Performance Study design and management (ISO 20916:2019 and ICH E6)

  • Clinical site selection, management and monitoring, including sample procurement

  • Clinical Evidence documentation including Performance Evaluation Plans/Reports and Scientific Validity

  • Technical file generation for submission to regulatory bodies (e.g. CE-IVDR)

  • Post-market surveillance and post-market performance follow-up studies

  • Supporting the IVDD to IVDR CE-marking transition

Further details of our clinical capabilities

1. Clinical Performance Study strategy, design and planning

  • Devise strategy to meet device-specific regulatory and product requirements

  • Advise on schedule and budget

  • Provide Clinical Strategy Document

2. Clinical site selection, management, and monitoring

  • Strong relationships with testing sites (EU, UK and US)

  • Identify sites based on e.g. population, facilities, expertise

  • Project management, oversight and monitoring

3. Submissions and notifications

  • Ethics committee submissions/renewal

  • Notifications to regulatory bodies

  • Annex XIV applications

4. Sample procurement and logistics

  • Import permits

  • Sample and material transport

  • Sample randomisation/anonymisation

5. Study protocol and report writing

  • Clinical Performance Study Plan

  • Statistical analysis/ data management/ monitoring plans

  • Clinical Performance Study Report

6. Performance evaluation plan and report writing

  • Performance Evaluation Plan

  • Performance Evaluation Report (Scientific Validity Report, Analytical Performance Report, Clinical Performance Report)

7. Post-market surveillance and post-market performance follow-up

  • Post-market surveillance planning and reporting

  • Post-market performance and claim extension study design, execution and documentation

APIS Clinical Compliance Services

APIS offers a Clinical and Regulatory Affairs consultancy service to help navigate the IVD regulatory environment across different regions (including CE-IVDR, UKCA, FDA).

For more information on this product please contact us.