POST-MARKET SURVEILLANCE

Post market surveillance is an area in which many organizations struggle and can run into problems as evidenced by a review of 483 and Warning Letter observations despite organizations devoting tremendous amounts of resources to ensure these functions operate as intended. Whether it is complaint handling and evaluation for medical device reportability; adverse event reporting for drug products, pharmacovigilance or compliance with EU MDR, organizations often struggle with effectively managing these important functional areas.

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JENLO Compliance can support your organization by developing an efficient, compliant system that allows you to focus on growing your business while ensuring you are collecting valuable data to serve as the early warning signal for identifying potential quality issues or continuous improvement goals and tying properly into your organizations other Quality systems such as CAPA and Design Controls.