Post-Market Surveillance

Medical device post-market surveillance (PMS) activities are described in the European Medical Device Directive (93/42/EEC) and are part of the Quality Management System (QMS) certification under EN ISO 13485:2016. However, resulting from various concerns surrounding PIP implants, PMS activities and oversight powers of Notified Bodies (NB) and Competent Authorities (CA) have been reinforced. Therefore, consequently, […]