Risk of Failing to Expand Distribution Channels for In-House-Developed Implants and Risk of Product Defects
First written in FY2018. 2 of 4 entries say "Restated". Latest entry: FY2021.
The whole theme swung hardest in 2026: 11 of 56 companies on the "Worse" side.
- FY2021MitigatedAnnual report
「To address these risks, the Group obtained ISO13485 certification, the quality management system standard for medical devices, and continually works to improve quality so that it can provide products and services that comply with laws and regulations and meet the expectations of medical institutions. In addition, to prepare for the possibility of causing serious damage due to a product defect or other issue, the Group maintains product liability insurance to reduce risk.」
ISO13485 certification and product liability insurance were identified as specific measures addressing implant quality and product liability risks. - FY2020RestatedAnnual report
「If expansion of sales channels does not progress as planned, or if a product defect results in the Group becoming liable under product liability laws, this could affect the Group's operating results and financial position.」
The risks of failing to expand sales channels for internally developed implants, as well as product defects and product liability, continued to be disclosed. - FY2019RestatedAnnual report
「If expansion of sales channels does not progress as planned, or if a product defect results in the Group becoming liable under product liability laws, this could affect the Group's operating results and financial position.」
The risks of failing to expand sales channels for internally developed implants, as well as product defects and product liability, were reconfirmed. - FY2018First statedAnnual report
「株式会社イーピーメディック conducts the manufacturing and sales business for orthopedic implants developed in-house. If distribution channels fail to expand as planned, or if a product defect gives rise to product liability, the Group’s business results and financial condition could be affected.」
The risks specific to the internally developed implants, namely failure to expand sales channels and product defects resulting in product liability, were identified.