[JPI Seminar] "Initial Judgment and Evidence Management Practices in Medical Device Recalls ~Legal Risks Caused by Delayed Recalls, Scope Errors, and Insufficient Explanations~" Held on April 22 (Wed)

JPI (Japan Planning Institute) is pleased to announce a seminar featuring Shinichiro Nakano, a lawyer and New York State attorney from Mori Hamada & Matsumoto. The seminar will provide a detailed explanation of initial judgment and evidence management practices in medical device recalls.

[Details and Application Here] https://www.jpi.co.jp/seminar/17694

[Title] Targeting "Managers and Practical Leaders in Reliability Assurance, Quality Assurance, and Legal Departments"

**Initial Judgment and Evidence Management Practices in Medical Device Recalls**

**~Legal Risks Caused by Delayed Recalls, Scope Errors, and Insufficient Explanations~**

[Date and Time] **Wednesday, April 22, 2026, 13:30 - 15:30** *Applications for archive distribution are also accepted after the seminar concludes.

[Lecturer] Mori Hamada & Matsumoto Lawyer New York State Attorney Shinichiro Nakano

[Lecture Overview] Emergencies such as recalls, responses to authorities, and lawsuits in medical device manufacturers occur suddenly, but their success or failure is largely determined by judgments and system design made during normal times.

In this seminar, a lawyer who has actually experienced product liability lawsuits and unannounced on-site inspections of medical devices will explain, based on real-world examples, how initial responses and documents for authorities are evaluated later, and how to smoothly cooperate with overseas headquarters.

It primarily targets managers and practical leaders involved in emergency responses in reliability assurance, quality assurance, and legal departments, providing a practical judgment framework and system design to prevent unnecessary costs and confusion during emergencies, and to minimize business impact.

[Lecture Items] **1. How should emergency responses for medical device manufacturers be viewed?**

(1) Emergencies occur suddenly, but as an extension of judgments made during normal times

(2) The decisive importance of "initial response design"

① Responding to defect reports and recalls before product liability lawsuits

② Responding to administrative guidance before unannounced on-site inspections

③ Irreversibility of documents and explanations created during initial response

(3) Responding to overseas headquarters ~For smooth progress~

① Importance of cooperation with overseas headquarters

② Causes of discrepancies ~Is it a language problem?~

**2. Practices of product liability lawsuits - How are defect reports and recall judgments evaluated later?