Simplice Tchounga

✓ Auditing supply chain process and warehouse according to ISO 13485: 2016

✓ Realizing gap analysis of processes according to MDR 2017/745 (articles 13 & 14)

✓ Labeling of medical devices according to ISO 15223-1: 2021

✓ Participating on inventory of medical devices

✓ Training colleagues on MDR 2017/745

✓ Validation of promotional and non-promotional materials related to medical devices (website, banner, emailing, posts, etc…) ✓ Managing non-conformities of Compliance department ✓ Writing procedure of regulatory watch for compliance activities ✓ Writing gap analysis form to assess evolution of standards and regulation ✓ Training colleagues on regulation for promotion of medical devices

✓ Updating Technical file of class Ir medical device for MDR compliance ✓ Writing GSPRs for MDR compliance ✓ Writing PMS Plan ✓ Writing Risk management Plan ✓ Writing procedure of regulatory monitoring intelligence ✓ Preparing registration of class Ir medical devices in UK