FIELD CORRECTIVE ACTIONS
Assessment, Scoping, Notification and Execution of Recalls, Corrections, Removals, Safety Alerts, and Market Withdrawals
Being able to recognize signals of how products are performing and when action is necessary can literally be a life and death decision in protecting patients of a violative product or when additional information should be communicated regarding safe and effective use of a product or of new adverse events. In addition, some firms are reluctant to enhance or improve existing products for fear that those enhancements could be viewed as corrections or 'silent recalls' by regulatory authorities.
JENLO Compliance has established processes to communicate properly to with stakeholders including customers, the general public as well as regulatory authorities. These processes comply with FDA regulations including 21 CFR Part 7, 806, 810 as well as EU MDR reporting requirements and communications to impacted Member States and Notified Bodies.