17th Apr. (Wed)

• 13:00

  14:40

  Medtec Innovation Awards Announcement

• 14:40

  15:00

  Medtec Innovation Awards Final Review

• 15:00

  15:20

  Medtec Innovation Awards Ceremony

• 15:20

  16:00

  keynote speechThe Future of the Medical Device Industry as Envisioned by the Ministry of Economy, Trade and Industry

  Ministry of Economy, Trade and Industry Commerce and Service Group
  Healthcare Industry Division Medical and Welfare Equipment Industry Office

• 16:10

  17:00

  Efforts and Achievements of Clinical Engineering Technician Association in Medical Engineering Collaboration: Striving to be the Best Partner in Medical Device Development

  Japan Association for Clinical Engineers

18th Apr. (Thu)

• 12:10

  13:00

  Special SessionSelecting the Best Sterilization Method for Medical Devices

  The lecture will explain, in an easy-to-understand manner for beginners and novices, what sterilization methods can be used for medical devices based on the Pharmaceutical Affairs Law, standards and criteria, what kind of sterilization method is best suited, the differences, features and key points of each sterilization method, using theory, rationale, and practical experience.

  Otsuka Techno Corporation

• 13:20

  13:50

  Gamma Sterilization Overview
  ～What is gamma sterilization? Characteristics of gamma sterilization compared to other sterilization methods and examples of sterilization of medical devices～

  KOGA ISOTOPE LTD.

• 14:10

  14:40

  Advancing Healthcare through PVD Coatings: The Benefits in Medical Applications

  Oerlikon Japan Co., Ltd.
  
  

• 15:00

  15:30

  Simulation Technology Becoming Essential for Medical Device Design
  ~Virtual testing now for catheters, stents, implants, etc.~

  JSOL CORPORATION
  
  

19th Apr. (Fri)

• 13:00

  13:30

  Toward Further Improvement of Quality Control System
  ~Cyber Security in the Application for the Pharmaceutical Affairs Act / Measurement Control Required by Standards and Laws~
  

  Japan Quality Assurance Organization

• 13:50

  14:20

  Hamamatsu University School of Medicine establishes "Hamamatsu Co-Creation Liaison Kanade Inc.
  ～ Join us and dive into the new sea of medical-industrial collaboration!～

  Hamamatsu University School of Medicine

• 14:40

  15:40

  ～No.1 in the number of new certifications under the Pharmaceutical Affairs Act for two consecutive years. Double Feature Presentation～
  1. Tips and tricks for smooth acquisition of the Pharmaceutical Affairs Act certification
  2. Let's learn the basics of the MDR under the EU AI Law. MDR/IVDR under EU AI Law and UK New Law

  BSI Group Japan K.K.

• 16:00

  16:30

  Designing and Developing for Cyber Security: Compliance with IEC 81001-5-1
  ~ Actual regulatory compliance with MDR, FDA and Japan, and regulatory trends in China, India, Brazil, etc.~

  Intertek Japan.

18th Apr. (Thu)

• 10:15

  11:15

  Investment opportunity for Japan Medical Industry in Medical Device Park, Gautam Buddha Nagar, Government of Uttar Pradesh, India

  Yamunna Expressway Industrial Development Authority

• 11:30

  12:00

  AI-Driven Medtech Ecosystems: Pioneering New Frontiers in Healthcare

  L&T Technology Services

• 13:00

  14:00

  Cyber Security Regulatory Requirements for Medical Devices

  TÜV SÜD Japan Ltd.

• 14:20

  15:20

  What's New MDR Technical Document Review, AI Act Gaining Attention

  TÜV Rheinland Japan Ltd.

• 15:40

  16:10

  Latest Medical OS Trends
  -Cyber Security Standards and Countermeasures in Medical Devices -

  Cybertrust Japan Co., Ltd.

19th Apr. (Fri)

• 13:00

  13:30

  【For medical device manufacturers/development divisions】Toward more efficient verification of application functions and actual equipment in medical device development

  Vector Japan Co., Ltd.

• 13:50

  14:20

  Methodology for understanding vulnerabilities in medical devices and systems

  Cybertrust Japan Co., Ltd.

• 14:40

  15:10

  The Future of Medical Device Documentation: What is Document Production, Management, and Translation for Rapid and Accurate Globalization?

  RWS Group

• 15:30

  16:30

  What is PMCF required under the European MDR?
  〜Introduction of PMCF survey using the latest digital platform〜

  ECLEVAR MEDTECH SAS

17th Apr. (Wed)

• 11:00

  12:00

  The Basics of Gamma Sterilization

  What is gamma radiation? How is it irradiated? In addition, we will introduce the products used, explain their advantages and points to be aware of in an easy-to-understand manner for beginners.

  KOGA ISOTOPE LTD.

• 12:30

  13:10

  Microbiological tests required for gamma sterilization

  Explains the methods, equipment, and precautions for microbiological testing necessary to guarantee sterilization for gamma sterilization

  KOGA ISOTOPE LTD.

• 13:10

  13:50

  ★Roundtable Discussion "Gamma Sterilization and Microbiological Testing"

  Gamma sterilization and microbiological testing will be presented in a roundtable discussion format

  Otsuka Techno Corporation × KOGA ISOTOPE LTD.

• 14:00

  15:00

  Validation of gamma sterilization

  The contents of the validation of gamma sterilization and the latest standard information will be explained

  KOGA ISOTOPE LTD.

• 15:10

  16:00

  Material changes due to gamma irradiation

  The mechanism of material changes caused by gamma irradiation and how to prevent changes will be explained

  KOGA ISOTOPE LTD.

18th Apr. (Thu)

• 10:30

  11:30

  Seminar & Roundtable Discussion "Contract Packaging Operations and Packaging Validation

  Packaging operations and packaging validation for sterile bags will be presented in the form of a seminar and roundtable discussion

  Otsuka Techno Corporation × SAKAKI L&E WISE Co., LTD.

• 13:00

  14:00

  EOG sterilization contract and logistics costs

  Explanation of EOG Sterilization contracting services and logistics costs related to contracting, and an overview of our contracting services

  SAKAKI L&E WISE Co., LTD.

• 14:00

  15:00

  ★Roundtable Discussion "Contract Processing, Packaging, EOG Sterilization and Logistics Operations"

  Roundtable discussion on the relationship between contract medical device manufacturing and logistics operations

  Otsuka Techno Corporation × SAKAKI L&E WISE Co., LTD.

• 15:30

  16:30

  Seminar & Roundtable Discussion "EOG Sterilization Validation"

  The half-cycle method we practice will be presented in the form of a seminar and roundtable discussion

  Otsuka Techno Corporation × SAKAKI L&E WISE Co., LTD.

19th Apr. (Fri)

• 11:00

  12:00

  "Basic Sterilization of Medical Devices"

  There are various methods of sterilization, but only a limited number of sterilization methods can be used for medical devices. The lecture will explain in an easy-to-understand manner for beginners and novices, using both theory and evidence and practical experience, what kind of sterilization method is best to choose based on laws (Pharmaceutical Equipment Law), standards and criteria, the differences between methods, features and key points, and the differences in sterilization equipment

  Otsuka Techno Corporation

• 12:00

  13:00

  ★Roundtable Discussion: "Which is better for sterilization, gamma rays or electron beams?"

  Japan Irradiation Service has facilities for both gamma rays and electron beams that can be used to sterilize medical devices
  *Facility tours are also available at any time

  Otsuka Techno Corporation × Japan Irradiation Service Co.,Ltd.

• 14:00

  15:00

  ★Roundtable Discussion "Creating Clean Molded Plastic Products”

  The presentation will also introduce water-cooled multilayer inflation film products used for cell culture and antistatic applications as examples of molded products

  Otsuka Techno Corporation × Otsuka Techno Corporation

• 15:30

  16:30

  ★Roundtable Discussion "Medical Device Packaging Materials and Process/Packaging Validation”

  The selection of packaging materials for medical devices varies depending on the product (medical device to be packaged) and sterilization method, and process and packaging validation based on ISO 11607 must be addressed

  Otsuka Techno Corporation × FUJIMORI SANGYO CO.,LTD.