医疗器械企业如何有效实施纠正和预防措施

How to Effectively Implement CAPA in Medical Device Industry

医疗器械质量体系法规和标准对纠正和预防措施均提出了要求,本文介绍了有效实施纠正和预防措施的步骤和程序,着重强调了纠正预防措施实施应关注有效性和充分性,避免流于形式。

Both of medical device regulation and quality system standard have the requirement to corrective and preventive action, this article introduce the step and procedure for effectively conduct corrective and preventive action, the corrective and preventive action should focus on effective and adequate and avoid externalism