[April 24 Free QMS Seminar] Overview of Revised QMSR

Thorough explanation of the new regulations based on ISO 13485 and changes in FDA inspections by an expert with over 25 years of experience.

Berry Co., Ltd. (Headquarters: Taito-ku, Tokyo, Representative Director: Yuji Nakano) will hold a free online seminar on Friday, April 24, 2026, titled "Overview of the Revised QMSR - What is the Impact of the Transition from QSR to QMSR in US Medical Device Regulations?", explaining the latest trends and practical responses to US medical device regulations.

On February 2, 2026, the FDA abolished the traditional Quality System Regulation (QSR: 21 CFR Part 820) and transitioned to the new QMSR (Quality Management System Regulation). As a result, medical device manufacturers targeting the US market are now required to operate a quality management system based on ISO 13485. In this seminar, Mr. Kiyoshi Tasaki (Withdom Consulting Group), who has been providing support for ISO 13485, US medical device regulations, and MDSAP for over 25 years, will explain the practical points of the revised QMSR in an easy-to-understand manner.

[Common Challenges in Exporting Medical Devices to the US Market] Companies exporting medical devices to the US market often face the following challenges when transitioning to QMSR.

- Unable to grasp the overall picture of what will change with the transition to QMSR. - Unaware of how the changes from the existing QSR will affect their own company. - Unsure how to develop a quality management system for export to the US. - Lacking information on how FDA inspections will change in the future. - Unable to clarify the relationship between ISO 13485 and QMSR. - Having poor knowledge about the possibility of FDA compliance using MDSAP.

Against the backdrop of these challenges, this seminar will systematically explain the overview of the revised QMSR and the direction of practical responses. To overcome the transition period after the abolition of QSR, we will provide the points that need to be understood now, based on abundant field experience.

[Background and Purpose of the Seminar] With the enforcement of QMSR in February 2026, medical device manufacturers for the US market are forced to make major revisions to their quality management systems. Unlike QSR, QMSR is structured to incorporate the requirements of ISO 13485, and even for companies that have already acquired ISO 13485 certification, it is essential to accurately understand the regulatory changes and their impact on their own QMS.

Especially for small and medium-sized medical device manufacturers and startups, it is required to balance QMS compliance and daily operations with limited resources. It is important to grasp the overall picture of the QMSR transition, clarify the necessary responses for your company, and then proceed with the development efficiently.

Therefore, in this seminar, Mr. Kiyoshi Tasaki of Withdom Consulting Group, who has been involved in practical support for QMSR, MDSAP, and ISO 13485 for over 25 years, will take the stage. He will explain the advantages and disadvantages of the revised QMSR, specific countermeasures for export to the US, and changes in FDA inspections from a perspective directly connected to the field.

[Event Overview] Date and Time: Friday, April 24, 2026, 14:00-15:30 Format: Online (scheduled via Zoom) Target Audience: QMS persons in charge, Quality Assurance Departments, Manufacturing Managers, Responsible Technicians