Medline France’s sterile procedure tray (SPT) component validation team was awarded the International Quality Assurance Award in December 2020 for commendable teamwork on the BSI remediation plan. This is an international quality award given by our Quality and Regulatory Affairs President once per year.
The BSI remediation plan involved the validation of numerous components in our SPTs. In fact, due to changes in the regulatory landscape, Medline decided to change its conformity assessment procedure from article 11 to article 12 within the MDD 93/42/EEC. In response, the team needed to work with each and every supplier to ensure compliance with the new conformity assessment.
The team was nominated by Emilie Sanchis (QA Senior Technical Validation Manager), and comprised Muriel Morand (Q/RA Component Validation Technician), Natacha Lecacheur (Q/RA Component Validation Technician), Florian Crosnier (Q/RA Component Validation Technician) and Christopher Ranguet (Components Validation Manager). All personnel actively worked with other SPT departments within Medline to remediate more than 2,900 components with 259 suppliers.