L3 In-Vitro Diagnostic Clinical Trials

As experts in the In Vitro Diagnostics (IVD) space, we provide comprehensive services to assist organizations with quality and regulatory strategy, and tactical execution.

Our team can help fulfill regulatory needs by working with your team or conducting an independent assessment. We align with your resources to focus our expertise in the areas you need, at the time you need.

L3 Quality and Regulatory Services Include:

• ISO 13485 gap analysis to the new 2016 regulatory standard
• Implementation of a compliant QMS to meet ISO 13485:2016
• Internal and Critical Supplier QMS Audits
• Management of Quality and Regulatory documentation Assistance with EU IVD Classification to meet the new IVDR Compilation and updates to European Technical Files
• Implementation of an effective Post-Market Surveillance system
• Coordination with the notifying body to update CE Mark of IVD products

Team

Our team is led by Dr. Mary Nunnally, and includes clinical trials professionals and consultants with extensive experience in in-vitro diagnostics clinical trials.