[Seminar] Practical Work on Initial Decision-Making and Evidence Management in Medical Device Recalls

basic information

【Lecture Overview】 Emergencies such as recalls, regulatory responses, and lawsuits in medical device manufacturing can occur unexpectedly, but their success or failure is greatly influenced by decisions and system designs made during normal times. In this seminar, a lawyer with actual experience in product liability lawsuits and unannounced inspections will explain, based on real examples, how initial responses and documents for regulatory authorities are evaluated later, as well as how to smoothly collaborate with overseas headquarters. The primary audience includes managers and responsible personnel from the reliability assurance, quality assurance, and legal departments involved in emergency responses, providing a practical framework for decision-making and system design to prevent unnecessary costs and confusion during emergencies, thereby minimizing the impact on business. 【Lecture Topics】 ■ How should we perceive emergency responses in medical device manufacturing? ■ Practical aspects of product liability lawsuits—how defect reports and recall decisions are evaluated later— ■ Practical responses to regulatory authorities triggered by advertising of unapproved medical devices—what happens when an unannounced inspection occurs— ■ Designing practical operations during normal times to assist in emergencies ■ Related Q&A ■ Business card and information exchange session ~ Attendance by members of law firms is discouraged ~

Price information

[Participation Fee] 1 person: 37,310 yen (tax included) From 2 people onwards: 32,310 yen (tax included / same organization, simultaneous application) *For those affiliated with local public organizations, up to 2 people can participate for 11,000 yen (tax included / venue and live streaming only)

Delivery Time

Applications/Examples of results

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