Background

Platelet Solutions Ltd is a spin-out company of the University of Nottingham formed in 2011, and is the outcome of many years of research and experience in the Thrombosis and Haemostasis Group. The company focuses on the provision of products and services for platelet function testing. Platelet function testing is required for diagnosis of abnormal bleeding and to monitor platelet function in those who are at-risk of vascular events such as heart attack or stroke. 

Previously, platelet function analysis had to be performed immediately after taking the blood sample but Platelet Solutions patented method allows samples to be processed using simple disposable kits and be posted for expert analysis.

They have been developing a new platelet processing kit that required CE mark certification ready for market launch.

 

The CHEATA Solution

Platelet Solutions Ltd engaged with CHEATA to undertake the following work:

  • To perform a gap analysis on the data already compiled for the Technical File against the applicable Essential Requirements of the IVD Medical Devices Directive
  • To deliver a list of recommended actions to achieve regulatory compliance with the IVD Directive
  • To outline the impact of the proposed changes to the IVD Regulations on the current regulatory position

Outcome

A comprehensive list of actions that enabled Platelet Solutions to understand and implement the necessary steps required in order to achieve regulatory compliance for their new product.

Platelet Solutions have now successfully achieved CE mark approval for their platelet processing kits.

http://www.plateletsolutions.co.uk

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